VIRILIS PENILE PROSTHESIS— 510(k) K983015

Name: FDA 510(k) clearance K983015
Creator: U.S. Food and Drug Administration
Published: 1999-02-05

Substantially Equivalent

Specialty Surgical Products, Inc.

FDA 510(k) clearance K983015 for VIRILIS PENILE PROSTHESIS, Substantially Equivalent on 1999-02-05. Applicant: Specialty Surgical Products, Inc.. Device class: 2.

Clearance details

Applicant: Specialty Surgical Products, Inc.
Product code: Code FTQ
Device class: Class 2
Regulation: 21 CFR 876.3630
Advisory panel: Gastroenterology, Urology
Date received: 1998-08-28
Decision date: 1999-02-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hamilton, MT, US

Download summary PDF View on FDA.gov ↗

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