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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 K102006
Device Name CRYOMEGA
Applicant
STC CONSULTING LLC
4093 MAULFAIR DRIVE
ALLENTOWN,  PA  18103
Applicant Contact R. SAM NIEDBALA
Correspondent
STC CONSULTING LLC
4093 MAULFAIR DRIVE
ALLENTOWN,  PA  18103
Correspondent Contact R. SAM NIEDBALA
Regulation Number878.4350
Classification Product Code
GEH  
Date Received07/16/2010
Decision Date 10/06/2010
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
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