CRYOPROBES MC-1400-CRYOSURG-CONSOLE

Unit, Cryosurgical, Accessories

SPEMBLY MEDICAL LTD.

The following data is part of a premarket notification filed by Spembly Medical Ltd. with the FDA for Cryoprobes Mc-1400-cryosurg-console.

Pre-market Notification Details

Device IDK832385
510k NumberK832385
Device Name:CRYOPROBES MC-1400-CRYOSURG-CONSOLE
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 Received1983-07-19
Decision Date1983-09-12

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