SIMPLICARE THIN FILM WOUND DRESSINGS
FDA 510(k) clearance K980209 · decided 1998-02-20
Clearance details
- K-number
- K980209
- Device name
- SIMPLICARE THIN FILM WOUND DRESSINGS
- Applicant
- Hollister, Inc.
- Decision
- Unknown
- Date received
- 1998-01-20
- Decision date
- 1998-02-20
- Days to decision
- 31 days
- Clearance type
- Traditional
- Product code
- MGP
- Device class
- U
- Medical specialty
- Unknown
- Advisory committee
- Unknown
- Location
- Libertyville, 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 |
|---|
| COLLATEK SHEET (K012995) | Biocore Medical Technologies, Inc. | 2001-10-25 |
| COLLATEK FOAM (K012997) | Biocore Medical Technologies, Inc. | 2001-10-25 |
| LASERSKIN DRESSING (K001508) | Fidia Advanced Biopolymers Srl | 2001-07-25 |
| FASTSEAL CHEST WOUND DRESSING (K990079) | Greenfield Medical Technologies, Inc. | 1999-12-23 |
| SIMPLICARE TRANSPARENT WOUND DRESSING (K991214) | Hollister, Inc. | 1999-10-14 |
| DERMAPHYLYX SKIN PROTECTORS, PROTECT IT SKIN PROTECTORS (K992302) | Dermaphylyx, Inc. | 1999-09-14 |
| GILTECH PLUS TRANSPARENT DRESSING (K992005) | Giltech Plus, Inc. | 1999-09-03 |
| DERMAPHYLYX FILM WOUND DRESSING AND HEALIAN FILM WOUND DRESSING (K990875) | Dermaphylyx, Inc. | 1999-05-27 |
| DERMAFLEX WOUND DRESSING, DERMAFLEX FOAM WOUND DRESSING, HEALIAFLEX WOUND DRESSING, HEALIAFOAM WOUND DRESSING (K990438) | Dermaphylyx, Inc. | 1999-03-25 |
| MEPITEL NON ADHERENT SILICONE DRESSING (K984371) | Molnlycke Health Care, Inc. | 1999-03-03 |
| INNOVATIVE TECHNOLOGIES HYDROCOLLOID AND INTELLIGENT HYDROCOLLOID WOUND DRESSINGS (K983303) | Innovative Technologies , Ltd. | 1998-12-09 |
| TIELLE PLUS HYDROPOLYMER ADHESIVE DRESSING (K983234) | Johnson & Johnson Medical, Div. of Ethicon, Inc. | 1998-11-25 |
Recalls involving this device
No recalls on record reference this clearance.