PROXIDERM, MODELS TN 460, TN 90 460, BK 460
FDA 510(k) clearance K982439 · decided 1998-09-08
Clearance details
- K-number
- K982439
- Device name
- PROXIDERM, MODELS TN 460, TN 90 460, BK 460
- Applicant
- Progressive Surgical Products, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1998-07-14
- Decision date
- 1998-09-08
- Days to decision
- 56 days
- Clearance type
- Traditional
- Product code
- MKY
- Device class
- 1
- Regulation number
- 878.4320
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Westbury, NY, 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 |
|---|---|---|
| WISEBANDS SKIN CLOSURE DEVICE (K002315) | Wisebands , Ltd. | 2001-03-15 |
| PROXIDERM (D-460,D 90 460,D 180,460, PS 460) (K970439) | Progressive Surgical Products, Inc. | 1997-04-16 |
| PHOENIX ETE TISSUE EXTENSION SYSTEM (K962144) | Phoenix Biomedical Corp. | 1997-01-14 |
| PROXIDERM (TENTATIVE) (K942425) | Progressive Surgical Products, Inc. | 1994-11-04 |
| SURE-CLOSURE II 75MM SKIN STRETCHING SYSTEM (K942526) | Life Medical Sciences, Inc. | 1994-07-19 |
Recalls involving this device
No recalls on record reference this clearance.