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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 K973035
Device Name VIOLA II DENTAL CAMERA SYSTEM
Applicant
Innovative Medical Systems, Inc.
55 Steamwhistle Dr.
Ivyland,  PA  18974
Applicant Contact KEVIN T SPURGEON
Correspondent
Innovative Medical Systems, Inc.
55 Steamwhistle Dr.
Ivyland,  PA  18974
Correspondent Contact KEVIN T SPURGEON
Regulation Number872.6640
Classification Product Code
EIA  
Date Received08/14/1997
Decision Date 09/24/1997
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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