PMA N17511S012

Device: HYSKON (32% DEXTRAN 70)
Applicant: Coopervision Surgical
PMA number: N17511
Supplement: S012
Product code: LTA
Decision date: 1997-12-30
Generic name: FLUID, HYSTEROSCOPY
Approval order 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.

Current openFDA PMA Record#

Device: HYSKON (32% DEXTRAN 70)
Applicant: Coopervision Surgical
PMA number: N17511
Supplement: S012
Product code: LTA
Generic name: FLUID, HYSTEROSCOPY
Decision date: 1997-12-30
Decision code: APPR
Date received: 1997-12-01
Supplement type: Normal 180 Day Track
Supplement reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order 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.