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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name instrument, biopsy, mechanical, gastrointestinal
510(k) Number K843477
Device Name PHARMA-PLAST RECTAL TIP
Applicant
ZIMMAR CONSULTING LTD.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
ZIMMAR CONSULTING LTD.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number876.1075
Classification Product Code
FCF  
Date Received09/06/1984
Decision Date 12/05/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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