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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Unit, Cryosurgical, Accessories
510(k) Number K060555
Device Name SPRAYGENIX CRYO ABLATION SYSTEM
Applicant
Crymed Technologies, Inc.
3225 Ellerslie Ave.
Third Floor, Suite B311
Baltimore,  MD  21218
Applicant Contact TIM ASKEW
Correspondent
Crymed Technologies, Inc.
3225 Ellerslie Ave.
Third Floor, Suite B311
Baltimore,  MD  21218
Correspondent Contact TIM ASKEW
Regulation Number878.4350
Classification Product Code
GEH  
Date Received03/02/2006
Decision Date 04/21/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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