STAGE- 1 TEMPORARY/HEALING CAP, MODEL 42021-42026
FDA 510(k) clearance K053643 · decided 2006-01-23
Clearance details
- K-number
- K053643
- Device name
- STAGE- 1 TEMPORARY/HEALING CAP, MODEL 42021-42026
- Applicant
- Lifecore Biomedical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2005-12-30
- Decision date
- 2006-01-23
- Days to decision
- 24 days
- Clearance type
- Special
- Product code
- NHA
- Device class
- 2
- Regulation number
- 872.3630
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Chaska, MN, 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 |
|---|---|---|
| GYNECARE INTERGEL ADHESION PREVENTION SOLUTION (P990015/S002) | Lifecore Biomedical, Inc. | 2003-03-18 |
| GYNECARE INTERGEL ADHESION PREVENTION SOLUTION (P990015/S001) | Lifecore Biomedical, Inc. | 2002-07-09 |
| INTERGEL ADHESION PREVENTION SOLUTION (P990015) | Lifecore Biomedical, Inc. | 2001-11-16 |