DEBRISAN (DEXTRANOMER) PASTE
FDA 510(k) clearance K800737 · decided 1980-08-04
Clearance details
- K-number
- K800737
- Device name
- DEBRISAN (DEXTRANOMER) PASTE
- Applicant
- Pharmaseal Laboratories
- Decision
- Substantially Equivalent
- Date received
- 1980-04-02
- Decision date
- 1980-08-04
- Days to decision
- 124 days
- Clearance type
- Traditional
- Product code
- KOZ
- Device class
- 1
- Regulation number
- 878.4018
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Mchenry, IL, 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 |
|---|---|---|
| INCARE PINSITE DRESSING (K905206) | Hollister, Inc. | 1991-04-12 |
| CUTINOVA HYDRO (K905688) | Beiersdorf, Inc. | 1991-04-01 |
| IODOSORB GEL (K905069) | Perstorp AB C/O Robert Joel Slomoff | 1991-01-31 |
| REDI-RELEASE ABSORBENT DRESSING (K904604) | Fountain Pharmaceuticals, Inc. | 1991-01-07 |
| BIOCLUSIVE(R) ABSORBENT DRESSING (K896828) | Johnson & Johnson International | 1990-11-21 |
| DERMASORB WOUND CONTACT LAYER DRESSING (K903645) | Convatec, A Division of E.R. Squibb & Sons | 1990-11-21 |
| ALLEVYN DRESSING CLAIMS CHANGE (K904412) | Smith & Nephew United, Inc. | 1990-10-23 |
| INTRASITE CAVITY WOUND DRESSING (LABEL REVISION) (K901876) | Smith & Nephew United, Inc. | 1990-06-28 |
| EXUSORB(TM) DRY/WET DRESSING (K896176) | Controlled Therapeutics Corp. | 1989-11-24 |
| INTRASITE CAVITY WOUND DRESSING (K895354) | Smith & Nephew United, Inc. | 1989-11-07 |
| ENVISAN PAD (K874552) | Marion Laboratories, Inc. | 1988-01-22 |
| DEBRISAN ABSORBENT PAD (K872453) | Pharmacia, Inc. | 1988-01-14 |
Recalls involving this device
No recalls on record reference this clearance.