ELASTIC BANDAGE— 510(k) K843056

Substantially Equivalent

Sterile Medical Systems

FDA 510(k) clearance K843056 for ELASTIC BANDAGE, Substantially Equivalent on 1984-12-04. Applicant: Sterile Medical Systems. Device class: 1.

Clearance details

Applicant: Sterile Medical Systems
Product code: Code GAX
Device class: Class 1
Regulation: 21 CFR 878.5900
Advisory panel: General, Plastic Surgery
Date received: 1984-08-03
Decision date: 1984-12-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: South Weymouth, MA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GAX

K931198 — UNIQUET1993-09-01
K881398 — TOURNIQUET1988-04-29
K881176 — STERILE ESMARCH BANDAGE1988-04-11
K875092 — DEGANIA SILICONE TOURNIQUET1988-01-07
K873928 — UNIVERSAL TOURNIQUET1987-10-23

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