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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 K911420
Device Name HISTOFREEZER
Applicant
SOLARCARE TECHNOLOGIES CORP,INC.
BEN FRANKLIN TECHNOLOGY CENTER
115 RESEARCH DRIVE
BETHLEHEM,  PA  18015
Applicant Contact SAM NIEDBALA
Correspondent
SOLARCARE TECHNOLOGIES CORP,INC.
BEN FRANKLIN TECHNOLOGY CENTER
115 RESEARCH DRIVE
BETHLEHEM,  PA  18015
Correspondent Contact SAM NIEDBALA
Regulation Number878.4350
Classification Product Code
GEH  
Date Received04/01/1991
Decision Date 06/28/1991
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
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