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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Carrier, Amalgam, Operative
510(k) Number K945220
Device Name AMALGAM CARRIER
Applicant
Buffalo Dental Mfg. Co., Inc.
99 Lafayette Dr.
Syosset,  NY  11791
Applicant Contact DONVIN M NEVIN
Correspondent
Buffalo Dental Mfg. Co., Inc.
99 Lafayette Dr.
Syosset,  NY  11791
Correspondent Contact DONVIN M NEVIN
Regulation Number872.4565
Classification Product Code
EKI  
Date Received10/26/1994
Decision Date 01/11/1995
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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