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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Unit, Syringe, Air And/Or Water
510(k) Number K931772
Device Name SURETIP SYRINGE TIP COVER
Applicant
Western M/D, Inc.
1320 Marsten Rd.
#A-B
Burlingame,  CA  94010
Applicant Contact ROBERT NERLI
Correspondent
Western M/D, Inc.
1320 Marsten Rd.
#A-B
Burlingame,  CA  94010
Correspondent Contact ROBERT NERLI
Regulation Number872.4565
Classification Product Code
ECB  
Date Received04/09/1993
Decision Date 03/07/1994
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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