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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 K842959
Device Name MC-4000 CONSOLE & PROBES
Applicant
Cryomedics, Inc.
500 Bostwick Ave.
Bridgeport,  CT  06605
Applicant Contact RICHARD E FRANKO
Correspondent
Cryomedics, Inc.
500 Bostwick Ave.
Bridgeport,  CT  06605
Correspondent Contact RICHARD E FRANKO
Regulation Number878.4350
Classification Product Code
GEH  
Date Received07/27/1984
Decision Date 12/07/1984
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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