GOODMAN BANDAGE
FDA 510(k) clearance K933085 · decided 1993-12-23
Clearance details
- K-number
- K933085
- Device name
- GOODMAN BANDAGE
- Applicant
- Megadyne Medical Products, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1993-06-23
- Decision date
- 1993-12-23
- Days to decision
- 183 days
- Clearance type
- Traditional
- Product code
- KGY
- Device class
- 1
- Regulation number
- 878.4100
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Draper, UT, 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 |
|---|---|---|
| TROCAR CATHETER (K913678) | Medovations, Inc. | 1991-12-16 |
| SURGICAL TISSUE POUCH (K910914) | Cook Urological, Inc. | 1991-03-28 |
| ISOLATION BAG 3M (K832318) | 3M Company | 1983-10-31 |
| BAND-AID BRAND TRICOT MESH BANDAGES (K801823) | Johnson & Johnson Professionals, Inc. | 1980-08-20 |
| BAND-AID BRAND FLEXIBLE FABRIC BANDAGE (K801824) | Johnson & Johnson Professionals, Inc. | 1980-08-20 |
Recalls involving this device
No recalls on record reference this clearance.