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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Burnisher, Operative
510(k) Number K911214
Device Name NUTIP (TM) SYRINGE SHIELD
Applicant
Western M/D, Inc.
P.O. Box 1552
Burlingame,  CA  94011
Applicant Contact ROBERT NERLI
Correspondent
Western M/D, Inc.
P.O. Box 1552
Burlingame,  CA  94011
Correspondent Contact ROBERT NERLI
Regulation Number872.4565
Classification Product Code
EKJ  
Date Received03/19/1991
Decision Date 07/17/1991
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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