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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, X-Ray, Stationary
510(k) Number K863309
Device Name REFURBISH DIAGNOSTIC X-RAY EQUIPMENT
Applicant
Chemarts and Assoc., Inc.
R.D.#3, 17 Bacton Hill Rd.
Frazer,  PA  19355
Applicant Contact GEORGE WARREN
Correspondent
Chemarts and Assoc., Inc.
R.D.#3, 17 Bacton Hill Rd.
Frazer,  PA  19355
Correspondent Contact GEORGE WARREN
Regulation Number892.1680
Classification Product Code
KPR  
Date Received08/27/1986
Decision Date 01/16/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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