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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Set, Administration, Intravascular
510(k) Number K823214
Device Name DOSIMETRIC RELEASE PROGRAM - ADMIN. SET
Applicant
Cutter Laboratories, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Cutter Laboratories, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number880.5440
Classification Product Code
FPA  
Date Received10/28/1982
Decision Date 01/12/1983
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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