FEMCAP
FDA premarket approval P020041/S003 · decided 2013-08-21
Approval details
- PMA number
- P020041
- Supplement
- S003
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- FEMCAP
- Generic name
- Cap, cervical, contraceptive
- Applicant
- Femcap Incorporated
- Date received
- 2013-03-08
- Decision date
- 2013-08-21
- Days to decision
- 166 days
- Decision code
- APPR
- Product code
- LLQ
- Advisory committee
- Obstetrics/Gynecology
- Expedited review
- No
- Location
- Warren, MI
- Statement
- APPROVAL FOR KDL PRECISION MOLDING CORPORATION, A MANUFACTURING SITE LOCATED IN PACOIMA, CALIFORNIA
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| FEMMYCYCLE (K121857) | Femcap Incorporated | 2012-11-15 |