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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Syringe, Piston
510(k) Number K820164
Device Name EMPTY STERILE CARPUJECT
Applicant
Sterling Drug, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Sterling Drug, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number880.5860
Classification Product Code
FMF  
Date Received01/20/1982
Decision Date 02/24/1982
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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