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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 K933327
Device Name HISTOFREEZER
Applicant
Solarcare, Inc.
1745 Eaton Ave.
Bethlehem,  PA  18018
Applicant Contact R. S NIEDBALA
Correspondent
Solarcare, Inc.
1745 Eaton Ave.
Bethlehem,  PA  18018
Correspondent Contact R. S NIEDBALA
Regulation Number878.4350
Classification Product Code
GEH  
Date Received07/08/1993
Decision Date 10/29/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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