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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Needle, Hypodermic, Single Lumen
510(k) Number K780209
Device Name DILUTION SPIKE
Applicant
Sterling Drug, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Sterling Drug, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number880.5570
Classification Product Code
FMI  
Date Received02/06/1978
Decision Date 04/10/1978
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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