HYSKON (32% DEXTRAN 70)
FDA premarket approval N17511/S012 · decided 1997-12-30
Approval details
- PMA number
- N17511
- Supplement
- S012
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- HYSKON (32% DEXTRAN 70)
- Generic name
- FLUID, HYSTEROSCOPY
- Applicant
- Coopervision Surgical
- Date received
- 1997-12-01
- Decision date
- 1997-12-30
- Days to decision
- 29 days
- Decision code
- APPR
- Product code
- LTA
- Advisory committee
- Obstetrics/Gynecology
- Expedited review
- No
- Location
- Trumbull, CT
- Statement
- Approval for a manufacturing facility located at NPBI, Nederlands Produktielaboratorium Voor, Bloedtransfusieapparatuur en Infusievloeistoffen B.V., Runde ZZ 41, 7881 HM Emmer-Compascuum, The Netherlands.
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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 |