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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Container, Liquid Medication, Graduated
510(k) Number K800213
Device Name PHARMACY ADDITIVE SYRINGE 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 Number880.6430
Classification Product Code
KYW  
Date Received02/01/1980
Decision Date 02/26/1980
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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