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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 K883354
Device Name VARIABLE KV INTREX VSK 60 - 90 KVP
Applicant
Keystone X-Ray, Inc.
3535 Rte. 66-Pkwy. 100-
Spruce Bldg.
Neptune Township,  NJ  07753
Applicant Contact CHARLES D GOEBEL
Correspondent
Keystone X-Ray, Inc.
3535 Rte. 66-Pkwy. 100-
Spruce Bldg.
Neptune Township,  NJ  07753
Correspondent Contact CHARLES D GOEBEL
Regulation Number872.1810
Classification Product Code
EAP  
Date Received08/09/1988
Decision Date 12/21/1988
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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