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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 K972662
Device Name CRYOGEN CRYOSURGICAL SYSTEM
Applicant
CRYOGEN, INC.
6199 CORNERSTONE COURT EAST
SUITE 106
SAN DIEGO,  CA  92121
Applicant Contact CHERYL L SHEA
Correspondent
CRYOGEN, INC.
6199 CORNERSTONE COURT EAST
SUITE 106
SAN DIEGO,  CA  92121
Correspondent Contact CHERYL L SHEA
Regulation Number878.4350
Classification Product Code
GEH  
Date Received07/03/1997
Decision Date 10/01/1997
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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