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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 K982280
Device Name CRYOPRO MAXI AND CRYOPRO MINI
Applicant
CORTEX TECHNOLOGY APS
1050 CONNECTICUT AVENUE NW
WASHINGTON,  DC  20036 -5339
Applicant Contact MARSHA WERTZBERGER
Correspondent
CORTEX TECHNOLOGY APS
1050 CONNECTICUT AVENUE NW
WASHINGTON,  DC  20036 -5339
Correspondent Contact MARSHA WERTZBERGER
Regulation Number878.4350
Classification Product Code
GEH  
Date Received06/30/1998
Decision Date 11/25/1998
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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