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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 K931486
Device Name INTREX VSK INTERORAL DENTAL X-RAY UNIT
Applicant
Keystone X-Ray, Inc.
3535 Rte. 66-Pkwy. 100-
Spruce Bldg.
Neptune Township,  NJ  07753
Applicant Contact ALAN R KEIM
Correspondent
Keystone X-Ray, Inc.
3535 Rte. 66-Pkwy. 100-
Spruce Bldg.
Neptune Township,  NJ  07753
Correspondent Contact ALAN R KEIM
Regulation Number872.1810
Classification Product Code
EAP  
Date Received03/24/1993
Decision Date 11/23/1993
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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