STERILE FILM DRAPE FENESTRATED W/ADHESIVE PATCH— 510(k) K850326

Name: FDA 510(k) clearance K850326
Creator: U.S. Food and Drug Administration
Published: 1985-02-26

Substantially Equivalent

Excel Health Care Products

FDA 510(k) clearance K850326 for STERILE FILM DRAPE FENESTRATED W/ADHESIVE PATCH, Substantially Equivalent on 1985-02-26. Applicant: Excel Health Care Products. Device class: 2.

Clearance details

Applicant: Excel Health Care Products
Product code: Code KKX
Device class: Class 2
Regulation: 21 CFR 878.4370
Advisory panel: General, Plastic Surgery
Date received: 1985-01-28
Decision date: 1985-02-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: S. Plainfield, NJ, US

Download summary PDF View on FDA.gov ↗

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More clearances from Excel Health Care Products

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K850960 — NON-ABSORBENT DRAPES & ABSORBENT TOWELS1986-03-15
K850456 — TRACHEOSTOMY CARE KIT1985-03-11
K850325 — STERILE SUTURE REMOVAL KIT1985-02-26
K850199 — POLY-LINED TOWEL/DRAPE LINE1985-02-21

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