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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 K875212
Device Name PXS MODEL PXS7-730EA DENTAL X-RAY SOURCE
Applicant
Kevex Corp.
320 El Pueblo Rd.
P.O. Box 66860
Scotts Valley,  CA  95066
Applicant Contact BRIAN SKILLICORN
Correspondent
Kevex Corp.
320 El Pueblo Rd.
P.O. Box 66860
Scotts Valley,  CA  95066
Correspondent Contact BRIAN SKILLICORN
Regulation Number872.1800
Classification Product Code
EHD  
Date Received12/18/1987
Decision Date 06/17/1988
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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