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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, Photofluorographic
510(k) Number K903808
Device Name AMSIS RDS, RADIOGRAPHIC DISCOGRAPHY KIT
Applicant
Advanced Med/Surg, Inc.
25590 Seaboard Ln.
Hayward,  CA  94545
Applicant Contact RONALD C ALLEN
Correspondent
Advanced Med/Surg, Inc.
25590 Seaboard Ln.
Hayward,  CA  94545
Correspondent Contact RONALD C ALLEN
Regulation Number892.1730
Classification Product Code
IZG  
Date Received08/20/1990
Decision Date 01/22/1991
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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