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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Airbrush
510(k) Number K955573
Device Name OPTIBLAST INTRAORAL SANDBLASTER
Applicant
Buffalo Dental Mfg. Co., Inc.
99 Lafayette Dr.
Syosset,  NY  11791
Applicant Contact DON M NEVIN
Correspondent
Buffalo Dental Mfg. Co., Inc.
99 Lafayette Dr.
Syosset,  NY  11791
Correspondent Contact DON M NEVIN
Regulation Number872.6080
Classification Product Code
KOJ  
Date Received12/07/1995
Decision Date 05/03/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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