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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Adhesive, Denture, Carboxymethylcellulose Sodium (40-100&)
510(k) Number K896821
Device Name OLYMPUS URETERO. & CIRCON ACMI URETERO. GUIDE
Applicant
North American Sterilization & Packaging Co.
15 White Lake Rd.
P.O. Box 923
Sparta,  NJ  07871
Applicant Contact A SCHLAKMAN
Correspondent
North American Sterilization & Packaging Co.
15 White Lake Rd.
P.O. Box 923
Sparta,  NJ  07871
Correspondent Contact A SCHLAKMAN
Regulation Number872.3410
Classification Product Code
KOQ  
Date Received12/04/1989
Decision Date 02/09/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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