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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instruments, Surgical, Cardiovascular
510(k) Number K851152
Device Name MC-4000 SURGICAL INSTRUMENTS CARDIOVASCULAR
Applicant
Cryomedics, Inc.
500 Bostwick Ave.
Bridgeport,  CT  06605
Applicant Contact RONALD J CLARK
Correspondent
Cryomedics, Inc.
500 Bostwick Ave.
Bridgeport,  CT  06605
Correspondent Contact RONALD J CLARK
Regulation Number870.4500
Classification Product Code
DWS  
Date Received03/21/1985
Decision Date 06/24/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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