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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 K980474
Device Name TELICAM
Applicant
Dental/Medical Diagnostic Systems, Inc.
3722 Ave. Sausalito
Irvine,  CA  92606
Applicant Contact GREG HOLLAND
Correspondent
Dental/Medical Diagnostic Systems, Inc.
3722 Ave. Sausalito
Irvine,  CA  92606
Correspondent Contact GREG HOLLAND
Regulation Number872.6640
Classification Product Code
EIA  
Date Received02/06/1998
Decision Date 04/13/1998
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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