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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Unit, X-Ray, Extraoral With Timer
510(k) Number K864474
Device Name DENTAL RADIOGRAPHIC 90, MODEL PM 2002 CC PANORAMIC
Applicant
Planmeca USA, Inc.
2428 Hanover Ave.
Richmond,  VA  23220
Applicant Contact GAY JACOBSEN
Correspondent
Planmeca USA, Inc.
2428 Hanover Ave.
Richmond,  VA  23220
Correspondent Contact GAY JACOBSEN
Regulation Number872.1800
Classification Product Code
EHD  
Date Received11/13/1986
Decision Date 11/26/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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