PROSTATIC URETHRO. BALLOON DILATATION CATHETER— 510(k) K873295

Name: FDA 510(k) clearance K873295
Creator: U.S. Food and Drug Administration
Published: 1989-07-31

Substantially Equivalent

Medi-Tech, Inc.

FDA 510(k) clearance K873295 for PROSTATIC URETHRO. BALLOON DILATATION CATHETER, Substantially Equivalent on 1989-07-31. Applicant: Medi-Tech, Inc.. Device class: 2.

Clearance details

Applicant: Medi-Tech, Inc.
Product code: Code KOE
Device class: Class 2
Regulation: 21 CFR 876.5520
Advisory panel: Gastroenterology, Urology
Date received: 1987-08-17
Decision date: 1989-07-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Watertown, MA, US

Download summary PDF View on FDA.gov ↗

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