CRYOMEDICS 5000 CRYOPROBES

Unit, Cryosurgical, Accessories

SPEMBLY MEDICAL LTD.

The following data is part of a premarket notification filed by Spembly Medical Ltd. with the FDA for Cryomedics 5000 Cryoprobes.

Pre-market Notification Details

Device IDK832140
510k NumberK832140
Device Name:CRYOMEDICS 5000 CRYOPROBES
ClassificationUnit, Cryosurgical, Accessories
Applicant SPEMBLY MEDICAL LTD. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeGEH  
CFR Regulation Number878.4350 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1983-06-28
Decision Date1983-08-12

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