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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 K891282
Device Name MIC-100 WITH CRYOPROBES
Applicant
Frigitronics of Connecticut, Inc.
770 River Rd.
P.O. Box 855
Shelton,  CT  06484
Applicant Contact FRANK HALLETT
Correspondent
Frigitronics of Connecticut, Inc.
770 River Rd.
P.O. Box 855
Shelton,  CT  06484
Correspondent Contact FRANK HALLETT
Regulation Number878.4350
Classification Product Code
GEH  
Date Received03/09/1989
Decision Date 06/15/1989
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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