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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laparoscope, General & Plastic Surgery
510(k) Number K942584
Device Name PUTMAN STABILIZER
Applicant
J. MICHAEL PUTMAN, M.D., P.A.
THREE LINCOLN CENTRE
5430 LBJ FREEWAY, SUITE 1540
DALLAS,  TX  75240
Applicant Contact DENNIS T GRIGGS
Correspondent
J. MICHAEL PUTMAN, M.D., P.A.
THREE LINCOLN CENTRE
5430 LBJ FREEWAY, SUITE 1540
DALLAS,  TX  75240
Correspondent Contact DENNIS T GRIGGS
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received06/01/1994
Decision Date 06/23/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
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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