TOURNIQUET— 510(k) K881398

Name: FDA 510(k) clearance K881398
Creator: U.S. Food and Drug Administration
Published: 1988-04-29

Substantially Equivalent

Barretta Products, Research and Development, Inc.

FDA 510(k) clearance K881398 for TOURNIQUET, Substantially Equivalent on 1988-04-29. Applicant: Barretta Products, Research and Development, Inc.. Device class: 1.

Clearance details

Applicant: Barretta Products, Research and Development, Inc.
Product code: Code GAX
Device class: Class 1
Regulation: 21 CFR 878.5900
Advisory panel: General, Plastic Surgery
Date received: 1988-04-04
Decision date: 1988-04-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mobile, AL, US

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Recent devices under product code GAX

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K931198 — UNIQUET1993-09-01
K881176 — STERILE ESMARCH BANDAGE1988-04-11
K875092 — DEGANIA SILICONE TOURNIQUET1988-01-07
K873928 — UNIVERSAL TOURNIQUET1987-10-23
K872003 — KINDERWRAP1987-06-23

Data sourced from openFDA. This site is unofficial and independent of the FDA.