ORTHO-LEVEL— 510(k) K822305

Substantially Equivalent

Frontier Products

FDA 510(k) clearance K822305 for ORTHO-LEVEL, Substantially Equivalent on 1982-08-20. Applicant: Frontier Products. Device class: 1.

Clearance details

Applicant: Frontier Products
Product code: Code HTH
Device class: Class 1
Regulation: 21 CFR 888.4600
Advisory panel: Orthopedic
Date received: 1982-07-27
Decision date: 1982-08-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code HTH

K861576 — SHORTENING OSTEOTOMY GUIDE1986-05-12
K841470 — REESE OSTEOTOMY GUIDE SYS1984-05-23

More clearances from Frontier Products

K831001 — UNICUFF-BLOOD PRESSURE CUFF1983-07-28
K812639 — UNICUFF1981-10-02
K801099 — UNICUF, BLOOD PRESSURE CUFF1980-05-30

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