PRE-PADDED PLASTER/PARIS BAND/SPLINTS— 510(k) K800752

Name: FDA 510(k) clearance K800752
Creator: U.S. Food and Drug Administration
Published: 1980-04-21

Substantially Equivalent

Ortho-Care, Inc.

FDA 510(k) clearance K800752 for PRE-PADDED PLASTER/PARIS BAND/SPLINTS, Substantially Equivalent on 1980-04-21. Applicant: Ortho-Care, Inc.. Device class: 1.

Clearance details

Applicant: Ortho-Care, Inc.
Product code: Code ITG
Device class: Class 1
Regulation: 21 CFR 890.3025
Advisory panel: Physical Medicine
Date received: 1980-04-04
Decision date: 1980-04-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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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

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