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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 K925967
Device Name MEDCAM
Applicant
Medcam USA, Inc.
4800 N. Federal Hwy.,
Suite 300-D
Boca Raton,  FL  33431
Applicant Contact GORDON GETZ
Correspondent
Medcam USA, Inc.
4800 N. Federal Hwy.,
Suite 300-D
Boca Raton,  FL  33431
Correspondent Contact GORDON GETZ
Regulation Number872.6640
Classification Product Code
EIA  
Date Received11/25/1992
Decision Date 08/24/1993
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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