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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name tourniquet, nonpneumatic
510(k) Number K864897
Device Name DALE VENIPUNCTURE TOURNIQUET, PRODUCT NO. 1335
Applicant
DALE MEDICAL PRODUCTS, INC.
7 CROSS ST.
P.O. BOX 1556
PLAINVILLE,  MA  02762
Applicant Contact DANIEL W MCELANEY
Correspondent
DALE MEDICAL PRODUCTS, INC.
7 CROSS ST.
P.O. BOX 1556
PLAINVILLE,  MA  02762
Correspondent Contact DANIEL W MCELANEY
Regulation Number878.5900
Classification Product Code
GAX  
Date Received12/15/1986
Decision Date 01/12/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
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