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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 K870236
Device Name PANORAMIC X-RAY MODEL PC-1000
Applicant
Panoramic Corp.
4628 E. State Blvd.
Fort Wayne,  IN  46815
Applicant Contact ERIC J STETZEL
Correspondent
Panoramic Corp.
4628 E. State Blvd.
Fort Wayne,  IN  46815
Correspondent Contact ERIC J STETZEL
Regulation Number872.1800
Classification Product Code
EHD  
Date Received01/21/1987
Decision Date 02/13/1987
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
Recalls CDRH Recalls
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