130 CRYO UNIT & ASSOC. CRYOPROBES & SPRAY

Unit, Cryosurgical, Accessories

SPEMBLY MEDICAL LTD.

The following data is part of a premarket notification filed by Spembly Medical Ltd. with the FDA for 130 Cryo Unit & Assoc. Cryoprobes & Spray.

Pre-market Notification Details

Device IDK882568
510k NumberK882568
Device Name:130 CRYO UNIT & ASSOC. CRYOPROBES & SPRAY
ClassificationUnit, Cryosurgical, Accessories
Applicant SPEMBLY MEDICAL LTD. NEWBURY ROAD ANDOVER HAMPSHIRE SP10 4DR England,  GB
ContactGordon Cook
CorrespondentGordon Cook
SPEMBLY MEDICAL LTD. NEWBURY ROAD ANDOVER HAMPSHIRE SP10 4DR England,  GB
Product CodeGEH  
CFR Regulation Number878.4350 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1988-06-22
Decision Date1988-09-27

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