DISPOSABLE SILICONE EPISTAXIS CATHETER— 510(k) K973656

Name: FDA 510(k) clearance K973656
Creator: U.S. Food and Drug Administration
Published: 1997-11-18

Substantially Equivalent

Specialty Surgical Products, Inc.

FDA 510(k) clearance K973656 for DISPOSABLE SILICONE EPISTAXIS CATHETER, Substantially Equivalent on 1997-11-18. Applicant: Specialty Surgical Products, Inc.. Device class: 1.

Clearance details

Applicant: Specialty Surgical Products, Inc.
Product code: Code EMX
Device class: Class 1
Regulation: 21 CFR 874.4100
Advisory panel: Ear, Nose, Throat
Date received: 1997-09-25
Decision date: 1997-11-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hamilton, MT, US

Download summary PDF View on FDA.gov ↗

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