RESPONSE EXTERNAL PENILE RIGIDITY DEVICE— 510(k) K900559

Name: FDA 510(k) clearance K900559
Creator: U.S. Food and Drug Administration
Published: 1990-05-02

Substantially Equivalent

Smith-Collins Pharmaceutical, Inc.

FDA 510(k) clearance K900559 for RESPONSE EXTERNAL PENILE RIGIDITY DEVICE, Substantially Equivalent on 1990-05-02. Applicant: Smith-Collins Pharmaceutical, Inc.. Device class: 2.

Clearance details

Applicant: Smith-Collins Pharmaceutical, Inc.
Product code: Code LKY
Device class: Class 2
Regulation: 21 CFR 876.5020
Advisory panel: Gastroenterology, Urology
Date received: 1990-02-07
Decision date: 1990-05-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: West Chester, PA, US

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