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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 K760780
Device Name DOUBLE-ENDED NEEDLE
Applicant
Travenol Laboratories, S.A.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Travenol Laboratories, S.A.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number880.5570
Classification Product Code
FMI  
Date Received10/05/1976
Decision Date 11/16/1976
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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