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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, Intraoral
510(k) Number K800063
Device Name XR-710
Applicant
PENNWALT CORP.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
PENNWALT CORP.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number872.1810
Classification Product Code
EAP  
Date Received01/11/1980
Decision Date 03/03/1980
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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