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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 K882436
Device Name LASER - 1000
Applicant
Panoramic Corp.
4321 Goshen Rd.
Ft. Wayne,  IN  46818
Applicant Contact ERIC J STETZEL
Correspondent
Panoramic Corp.
4321 Goshen Rd.
Ft. Wayne,  IN  46818
Correspondent Contact ERIC J STETZEL
Regulation Number872.1800
Classification Product Code
EHD  
Date Received06/14/1988
Decision Date 08/04/1988
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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