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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Unit, Operative Dental
510(k) Number K951238
Device Name SAFE-TIPS EZ
Applicant
Safe Wave Products, Inc.
460 B Sovereign Ct.
Ballwin,  MO  63011
Applicant Contact BERNARD ESROCK
Correspondent
Safe Wave Products, Inc.
460 B Sovereign Ct.
Ballwin,  MO  63011
Correspondent Contact BERNARD ESROCK
Regulation Number872.6640
Classification Product Code
EIA  
Date Received03/20/1995
Decision Date 05/23/1995
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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