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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cassette, Radiographic Film
510(k) Number K945858
Device Name X-RAY FILM CASSETTE
Applicant
J.P.I. Chicago Co.
2451 Unite Ln.
Elk Grove,  IL  60007
Applicant Contact J O'GRADY
Correspondent
J.P.I. Chicago Co.
2451 Unite Ln.
Elk Grove,  IL  60007
Correspondent Contact J O'GRADY
Regulation Number892.1850
Classification Product Code
IXA  
Date Received12/01/1994
Decision Date 03/21/1995
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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