AQUAPLAST TIE DOWN DRESSING
FDA 510(k) clearance K943871 · decided 1994-09-30
Clearance details
- K-number
- K943871
- Device name
- AQUAPLAST TIE DOWN DRESSING
- Applicant
- Wfr/Aquaplast Corp.
- Decision
- Substantially Equivalent
- Date received
- 1994-08-08
- Decision date
- 1994-09-30
- Days to decision
- 53 days
- Clearance type
- Traditional
- Product code
- LZM
- Device class
- 1
- Regulation number
- 878.4014
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Wyckoff, 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 |
|---|---|---|
| GRAFT GUARD (K885136) | Sorex Medical | 1989-02-06 |
Recalls involving this device
No recalls on record reference this clearance.