ERECXEL ADJUSTABLE PENILE BANDS, CONTREX ADJUSTABLE PENILE BANDS— 510(k) K993343

Name: FDA 510(k) clearance K993343
Creator: U.S. Food and Drug Administration
Published: 2000-03-20

Substantially Equivalent

Erecxel Enterprises

FDA 510(k) clearance K993343 for ERECXEL ADJUSTABLE PENILE BANDS, CONTREX ADJUSTABLE PENILE BANDS, Substantially Equivalent on 2000-03-20. Applicant: Erecxel Enterprises. Device class: 2.

Clearance details

Applicant: Erecxel Enterprises
Product code: Code LKY
Device class: Class 2
Regulation: 21 CFR 876.5020
Advisory panel: Gastroenterology, Urology
Date received: 1999-10-05
Decision date: 2000-03-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Los Angeles, CA, US

Download summary PDF View on FDA.gov ↗

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