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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name camera, multi format, radiological
510(k) Number K923481
Device Name PHILIPS LASER DISK ARCHIVE
Applicant
PHILIPS MEDICAL SYSTEMS, INC.
710 BRIDGEPORT AVE.
P.O. BOX 860
SHELTON,  CT  06484
Applicant Contact WILLIAM G MCMAHON
Correspondent
PHILIPS MEDICAL SYSTEMS, INC.
710 BRIDGEPORT AVE.
P.O. BOX 860
SHELTON,  CT  06484
Correspondent Contact WILLIAM G MCMAHON
Regulation Number892.2040
Classification Product Code
LMC  
Date Received07/15/1992
Decision Date 05/05/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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