HYSKON (32% DEXTRAN 70)
FDA premarket approval N17511/S011 · decided 1995-07-18
Approval details
- PMA number
- N17511
- Supplement
- S011
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- HYSKON (32% DEXTRAN 70)
- Generic name
- FLUID, HYSTEROSCOPY
- Applicant
- Coopervision Surgical
- Date received
- 1994-11-10
- Decision date
- 1995-07-18
- Days to decision
- 250 days
- Decision code
- APPR
- Product code
- LTA
- Advisory committee
- Obstetrics/Gynecology
- Expedited review
- No
- Location
- Trumbull, CT
- Statement
- APPROVAL FOR THE USE OF A LAGARDE STERILIZER, 551015, IN YOUR CLAYTON, N.C. FACILITY TO TERMINALLY STERILIZE HYSKON HYSTEROSCOPY FLUID, 32% (DEXTRAN 70) IN 100 ML TO 250 ML GLASS BOTTLE:TRANSFER OF OWNERSHIP TO MADISAN PHARMACEUTICALS, INC.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| XENON LIGHT SOURCE AND ACCESSORIES (K921390) | Coopervision Surgical | 1992-07-27 |
| LEEP SYSTEM 6000 ELECTROSURGICAL UNIT AND ACCESSOR (K905747) | Coopervision Surgical | 1991-09-17 |