MEDDRAINS
FDA 510(k) clearance K931607 · decided 1993-08-06
Clearance details
- K-number
- K931607
- Device name
- MEDDRAINS
- Applicant
- Armm, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1993-04-01
- Decision date
- 1993-08-06
- Days to decision
- 127 days
- Clearance type
- Traditional
- Product code
- GBN
- Device class
- 1
- Regulation number
- 878.4200
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Huntington Beach, CA, 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 |
|---|---|---|
| SURGEONS CHOICE STAPLE, REMOVE/IMPLANT (K802783) | Hospital Products Intl. | 1980-12-16 |
Recalls involving this device
No recalls on record reference this clearance.