ARTHROSCOPY CAMERA DRAPE— 510(k) K915214

Substantially Equivalent

O.R. Concepts, Inc.

FDA 510(k) clearance K915214 for ARTHROSCOPY CAMERA DRAPE, Substantially Equivalent on 1992-01-09. Applicant: O.R. Concepts, Inc.. Device class: 2.

Clearance details

Applicant: O.R. Concepts, Inc.
Product code: Code KKX
Device class: Class 2
Regulation: 21 CFR 878.4370
Advisory panel: General, Plastic Surgery
Date received: 1991-11-18
Decision date: 1992-01-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Roanoke, TX, US

Download summary PDF View on FDA.gov ↗

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More clearances from O.R. Concepts, Inc.

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K935645 — FLOWGUN REUSABLE IRRIGATION PROBES1994-03-07
K926242 — ORC ENDOSCOPIC MONOPOLAR ELECTROSURGICAL PROBE1993-10-15

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