SERIES 40 & SERIES 42 CRYOPROBES (R SERIES)

Unit, Cryosurgical, Accessories

SPEMBLY MEDICAL LTD.

The following data is part of a premarket notification filed by Spembly Medical Ltd. with the FDA for Series 40 & Series 42 Cryoprobes (r Series).

Pre-market Notification Details

Device IDK882962
510k NumberK882962
Device Name:SERIES 40 & SERIES 42 CRYOPROBES (R SERIES)
ClassificationUnit, Cryosurgical, Accessories
Applicant SPEMBLY MEDICAL LTD. NEWBURY ROAD ANDOVER HAMPSHIRE SP10 4DR England,  GB
ContactCook
CorrespondentCook
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 Received1988-07-14
Decision Date1988-08-08

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