REPRO-MED - THD ADDRESS CHANGE / MANU. FACILITY
FDA premarket approval P820034/S003 · decided 1993-04-28
Approval details
- PMA number
- P820034
- Supplement
- S003
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- REPRO-MED - THD ADDRESS CHANGE / MANU. FACILITY
- Generic name
- DEVICE, TESTICULAR HYPOTHERMIA
- Applicant
- Repro-Med Systems, Inc.
- Date received
- 1992-05-14
- Decision date
- 1993-04-28
- Days to decision
- 349 days
- Decision code
- APPR
- Product code
- LOA
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- New York, NY
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| RMS SUBCUTANEOUS NEEDLE SET (K102512) | Repro-Med Systems, Inc. | 2011-05-20 |
| RESTORE VACUUM ERECTION DEVICE, CONFIDE VACUUM ERECTION DEVICE, PEP (PENILE ERECTION PROGRAM), RELY VACUUM ERECTION DEV) (K981506) | Repro-Med Systems, Inc. | 1998-06-25 |
| FREEDOM 60 SYRINGE INFUSION PUMP SYSTEM WITH SYRINGE SET & TUBING (K933652) | Repro-Med Systems, Inc. | 1994-05-18 |
| REPRO-MED EMERGENCY AIRWAY VACUUM SYSTEM (K894299) | Repro-Med Systems, Inc. | 1989-09-22 |
| REPRO-MED NEONATE ASPIRATION SYSTEM (K892529) | Repro-Med Systems, Inc. | 1989-06-12 |
| REPRO-MED SYSTEMS INFUSION DEVICE (K844401) | Repro-Med Systems, Inc. | 1985-03-12 |