DERMASTRIP
FDA 510(k) clearance K883660 · decided 1989-02-08
Clearance details
- K-number
- K883660
- Device name
- DERMASTRIP
- Applicant
- Bd Becton Dickinson Vacutainer Systems Preanalytic
- Decision
- Substantially Equivalent
- Date received
- 1988-08-26
- Decision date
- 1989-02-08
- Days to decision
- 166 days
- Clearance type
- Traditional
- Product code
- KGX
- Device class
- 1
- Regulation number
- 880.5240
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Franklin Lakes, NJ, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| SERAGARD INJECTION PATCH (K001240) | Platinum Services, Inc. | 2000-06-21 |
| CARE BAND ANTIBACTERIAL BANDAGES (K983368) | Aso Corp. | 1999-02-17 |
| SYVEK PATCH (K972914) | Marine Polymer Technologies, Inc. | 1997-12-22 |
| ADHESIVE BANDAGES WITH OTC DRUG (K943314) | Johnson & Johnson Consumer Products, Inc. | 1996-01-17 |
| TARGETT PATCH (K952606) | Cutting Edge Technologies, Inc. | 1995-12-21 |
| PARALLEL (K954007) | Johnson & Johnson Consumer Products, Inc. | 1995-11-22 |
| DERMIVIEW HYPOALLERGENIC CLEAR TAPE (K944587) | Johnson & Johnson Medical, Inc. | 1995-10-30 |
| STERILE PLASTIC DRESSING (K944588) | Smith & Nephew, Inc. | 1994-11-07 |
| BAND-AID BRAND ADHESIVE BANDAGES, SPORT STRIP (K941788) | Johnson & Johnson Consumer Products, Inc. | 1994-10-03 |
| BAND-AID(TM) BRAND ADHESIVE BANDAGE (K940536) | Johnson & Johnson Consumer Products, Inc. | 1994-10-03 |
| SHIPPERT PRESSURE BANDAGE (K940798) | Denver Splint Co. | 1994-09-28 |
| EMPI TAPE PATCHES (K941389) | Empi | 1994-08-23 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| OXYCELL (N5798/S007) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1995-07-24 |
| OXYCEL OXIDIZED (N5798/S005) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1991-02-08 |
| OXYCELL (N5798/S006) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1991-02-08 |
| MINI BALLOON (P780011/S012) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1989-10-30 |
| MINI BALLOON (P780011/S011) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1988-10-18 |
| MINI BALLOON (P780011/S010) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1988-01-29 |
| MINI BALLOON (P780011/S007) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1985-01-23 |
| BBL SCEPTOR SYSTEM MICRODILUTION ANTIMICROBIC SUSC (P800030/S006) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1984-11-05 |