HEXCELITE SHEET SPLINTS— 510(k) K760841

Substantially Equivalent

Hexcel Medical

FDA 510(k) clearance K760841 for HEXCELITE SHEET SPLINTS, Substantially Equivalent on 1976-11-01. Applicant: Hexcel Medical. Device class: 1.

Clearance details

Applicant: Hexcel Medical
Product code: Code ITG
Device class: Class 1
Regulation: 21 CFR 890.3025
Advisory panel: Physical Medicine
Date received: 1976-10-13
Decision date: 1976-11-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code ITG

K873111 — CONFORMA(TM) PLASTER BANDAGES1987-10-09
K862115 — DEKNA BAND KIT1986-08-19
K842573 — T.P.G. CAST TAPE1984-08-10
K840416 — HEXCELITE1984-03-23
K833732 — NON WETTING UNDERCAST PADDING1983-12-12

More clearances from Hexcel Medical

K820890 — URETHANE ORTHOPAEDIC CASTING TAPE1982-06-23
K812669 — SEATTLE II TOTAL HIP SYSTEM1981-10-02
K812687 — BRIGHAM II TOTAL HIP SYSTEM1981-10-02
K812068 — PROPOSED CONTROLS FOR DOSIMETRIC RELEASE1981-09-08
K811164 — URETHANE ORTHOPAEDIC CASTING TAPE1981-05-27

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