510(k) K864897

DALE VENIPUNCTURE TOURNIQUET, PRODUCT NO. 1335 by Dale Medical Products, Inc. — Product Code GAX

K864897 is an FDA 510(k) premarket notification submitted by Dale Medical Products, Inc. for the device "DALE VENIPUNCTURE TOURNIQUET, PRODUCT NO. 1335". The FDA issued a decision of Substantially Equivalent on January 12, 1987. The device falls under product code GAX (Tourniquet, Nonpneumatic), a Class I device regulated under 21 CFR 878.5900. Dale Medical Products, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 12, 1987
Date Received
December 15, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tourniquet, Nonpneumatic
Device Class
Class I
Regulation Number
878.5900
Review Panel
SU
Submission Type