ERECTION INDUCER DEVICE (EID)— 510(k) K896060

Name: FDA 510(k) clearance K896060
Creator: U.S. Food and Drug Administration
Published: 1990-03-20

Substantially Equivalent

Performance Medical, Inc.

FDA 510(k) clearance K896060 for ERECTION INDUCER DEVICE (EID), Substantially Equivalent on 1990-03-20. Applicant: Performance Medical, Inc.. Device class: 2.

Clearance details

Applicant: Performance Medical, Inc.
Product code: Code LKY
Device class: Class 2
Regulation: 21 CFR 876.5020
Advisory panel: Gastroenterology, Urology
Date received: 1989-10-18
Decision date: 1990-03-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Great Neck, NY, US

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Data sourced from openFDA. This site is unofficial and independent of the FDA.