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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 K891352
Device Name MARLOW ANAL SPECULUM
Applicant
Simpson/Basye, Inc.
430 Ayre St.
Wilmington,  DE  19804
Applicant Contact ROBERT A BASYE
Correspondent
Simpson/Basye, Inc.
430 Ayre St.
Wilmington,  DE  19804
Correspondent Contact ROBERT A BASYE
Regulation Number876.4730
Classification Product Code
KOA  
Date Received03/10/1989
Decision Date 06/23/1989
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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