BIODERM MEDICAL TRANSPARENT FILM DRESSING
FDA 510(k) clearance K951842 · decided 1995-06-12
Clearance details
- K-number
- K951842
- Device name
- BIODERM MEDICAL TRANSPARENT FILM DRESSING
- Applicant
- Bioderm, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1995-04-20
- Decision date
- 1995-06-12
- Days to decision
- 53 days
- Clearance type
- Traditional
- Product code
- MGP
- Device class
- U
- Medical specialty
- Unknown
- Advisory committee
- Unknown
- Location
- Wheaton, 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.