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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Surgical Instruments, G-U, Manual (And Accessories)
510(k) Number K863273
Device Name MARTIN MEDICAL PRO-SCOPE ANOSCOPE
Applicant
Martin Medical
36270 W. 103rd St.
P.O. Box 590
Desoto,  KS  66018
Applicant Contact RANDY KILBURN
Correspondent
Martin Medical
36270 W. 103rd St.
P.O. Box 590
Desoto,  KS  66018
Correspondent Contact RANDY KILBURN
Regulation Number876.4730
Classification Product Code
KOA  
Date Received08/25/1986
Decision Date 11/04/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
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