CRYMED CRYO-ABLATOR

Unit, Cryosurgical, Accessories

CRYMED TECHNOLOGIES, INC.

The following data is part of a premarket notification filed by Crymed Technologies, Inc. with the FDA for Crymed Cryo-ablator.

Pre-market Notification Details

Device IDK040809
510k NumberK040809
Device Name:CRYMED CRYO-ABLATOR
ClassificationUnit, Cryosurgical, Accessories
Applicant CRYMED TECHNOLOGIES, INC. 319 W. TIMONIUM RD. Lutherville,  MD  21093
ContactFrank Majerowicz
CorrespondentFrank Majerowicz
CRYMED TECHNOLOGIES, INC. 319 W. TIMONIUM RD. Lutherville,  MD  21093
Product CodeGEH  
CFR Regulation Number878.4350 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-03-29
Decision Date2004-05-21
Summary:summary

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