TRI-MED QUICK-STEP(TM) RECTAL TUBE— 510(k) K924549

Name: FDA 510(k) clearance K924549
Creator: U.S. Food and Drug Administration
Published: 1994-02-10

Substantially Equivalent

Tri-Med Specialties, Inc.

FDA 510(k) clearance K924549 for TRI-MED QUICK-STEP(TM) RECTAL TUBE, Substantially Equivalent on 1994-02-10. Applicant: Tri-Med Specialties, Inc.. Device class: 2.

Clearance details

Applicant: Tri-Med Specialties, Inc.
Product code: Code GBT
Device class: Class 2
Regulation: 21 CFR 876.5980
Advisory panel: Gastroenterology, Urology
Date received: 1992-09-09
Decision date: 1994-02-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Overland Park, KS, US

Download summary PDF View on FDA.gov ↗

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