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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mirror, Mouth
510(k) Number K946073
Device Name ORALVUE DENTAL MIRROR
Applicant
Hines Group , Ltd.
1562 First Ave.
Suite 356
Nyw York,  NY  10028
Applicant Contact RANDALPH DINES
Correspondent
Hines Group , Ltd.
1562 First Ave.
Suite 356
Nyw York,  NY  10028
Correspondent Contact RANDALPH DINES
Regulation Number872.4565
Classification Product Code
EAX  
Date Received12/07/1994
Decision Date 02/16/1995
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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