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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 K871958
Device Name SPACEMISER 8-17 FILM RECORDER
Applicant
FRANTZ IMAGING, INC.
17744 SKYPARK BLVD.
STE 165
IRVINE,  CA  92714 -6404
Applicant Contact ROBERT B KEETHLER
Correspondent
FRANTZ IMAGING, INC.
17744 SKYPARK BLVD.
STE 165
IRVINE,  CA  92714 -6404
Correspondent Contact ROBERT B KEETHLER
Regulation Number892.2040
Classification Product Code
LMC  
Date Received05/20/1987
Decision Date 06/22/1987
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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