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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name retractor
510(k) Number K844177
Device Name COSGROVE MITRAL VALVE RETRACTOR
Applicant
KAPP SURGICAL INSTRUMENT, INC.
2888 DETROIT AVE.
CLEVELAND,  OH  44113
Applicant Contact ALBERT E SANTILLI
Correspondent
KAPP SURGICAL INSTRUMENT, INC.
2888 DETROIT AVE.
CLEVELAND,  OH  44113
Correspondent Contact ALBERT E SANTILLI
Regulation Number878.4800
Classification Product Code
GAD  
Date Received10/25/1984
Decision Date 11/08/1984
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
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