UNIQUET— 510(k) K931198

Substantially Equivalent

Icat Systems

FDA 510(k) clearance K931198 for UNIQUET, Substantially Equivalent on 1993-09-01. Applicant: Icat Systems. Device class: 1.

Clearance details

Applicant: Icat Systems
Product code: Code GAX
Device class: Class 1
Regulation: 21 CFR 878.5900
Advisory panel: General, Plastic Surgery
Date received: 1993-03-09
Decision date: 1993-09-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Leandro, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GAX

K881398 — TOURNIQUET1988-04-29
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.