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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 K872825
Device Name AXIAL TOME, 60, FLUORO AND TOMAX
Applicant
Axialtome Corp.
1095-A Industrial Rd.
San Carlos,  CA  94070
Applicant Contact PHILLIP C MCARDLE
Correspondent
Axialtome Corp.
1095-A Industrial Rd.
San Carlos,  CA  94070
Correspondent Contact PHILLIP C MCARDLE
Regulation Number872.1800
Classification Product Code
EHD  
Date Received07/16/1987
Decision Date 03/31/1988
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
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