MOPYLEN
FDA 510(k) clearance K922630 · decided 1992-10-20
Clearance details
- K-number
- K922630
- Device name
- MOPYLEN
- Applicant
- S. Jackson, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1992-06-03
- Decision date
- 1992-10-20
- Days to decision
- 139 days
- Clearance type
- Traditional
- Product code
- GAW
- Device class
- 2
- Regulation number
- 878.5010
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Alexandria, VA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| SUPRAMID EXTRA SUTURES (N80838/S017) | S. Jackson, Inc. | 1990-01-26 |
| SUPRAMID EXTRA SUTURES (N80838/S016) | S. Jackson, Inc. | 1989-10-19 |
| SUPRAMID EXTRA SUTURES (N80838/S014) | S. Jackson, Inc. | 1989-08-02 |
| SUPRAMID EXTRA SUTURES (N80838/S015) | S. Jackson, Inc. | 1989-06-08 |
| SUPRAMID EXTRA SUTURES (N80838/S013) | S. Jackson, Inc. | 1988-08-31 |
| SUPRAMID EXTRA SUTURES (N80838/S012) | S. Jackson, Inc. | 1987-09-09 |
| SUPRAMID EXTRA SUTURES (N80838/S011) | S. Jackson, Inc. | 1987-06-29 |
| SUPRAMID EXTRA SUTURES (N80838/S010) | S. Jackson, Inc. | 1986-08-05 |