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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Endoscope Introducer Kit
510(k) Number K874045
Device Name PHARMASEAL ENDOSCOPY PREP KIT UPPER AND LOWER
Applicant
American Pharmaseal Div. Ahsc
27200 N. Tourney Rd.
Post Office Box 5900
Valencia,  CA  91355
Applicant Contact ROBERT T MERRICK
Correspondent
American Pharmaseal Div. Ahsc
27200 N. Tourney Rd.
Post Office Box 5900
Valencia,  CA  91355
Correspondent Contact ROBERT T MERRICK
Regulation Number876.1500
Classification Product Code
NWU  
Date Received10/05/1987
Decision Date 12/03/1987
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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