GLOVES, APARTICULATE SURGICAL
FDA 510(k) clearance K760248 · decided 1976-08-09
Clearance details
- K-number
- K760248
- Device name
- GLOVES, APARTICULATE SURGICAL
- Applicant
- Deknatel, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1976-07-19
- Decision date
- 1976-08-09
- Days to decision
- 21 days
- Clearance type
- Traditional
- Product code
- KGO
- Device class
- 1
- Regulation number
- 878.4460
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Fall River, MA, 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.
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| NONABSORBABLE SURG. SUTURES, BRAIDED SILK (N84348/S006) | Deknatel, Inc. | 1989-06-16 |
| NONABSORBABLE SURG. SUTURES, NYLON (N85060/S007) | Deknatel, Inc. | 1989-06-16 |
| DEKLENE(TM) (P810028/S011) | Deknatel, Inc. | 1989-06-16 |
| DEKLENE(TM) (P810028/S010) | Deknatel, Inc. | 1989-02-02 |
| NONABSORBABLE SURG. SUTURES, NYLON (N85060/S005) | Deknatel, Inc. | 1989-01-31 |
| DEKLENE(TM) (P810028/S008) | Deknatel, Inc. | 1989-01-31 |
| CHROMIC GUT SUTURE (N84381/S007) | Deknatel, Inc. | 1989-01-31 |
| NONABSORBABLE SURG. SUTURES, BRAIDED SILK (N84348/S004) | Deknatel, Inc. | 1989-01-31 |