IMPAX, MALE IMPOTENCE AID— 510(k) K861468

Substantially Equivalent

Lehigh Group

FDA 510(k) clearance K861468 for IMPAX, MALE IMPOTENCE AID, Substantially Equivalent on 1986-06-18. Applicant: Lehigh Group. Device class: 2.

Clearance details

Applicant: Lehigh Group
Product code: Code LKY
Device class: Class 2
Regulation: 21 CFR 876.5020
Advisory panel: Gastroenterology, Urology
Date received: 1986-04-21
Decision date: 1986-06-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Concord, MA, 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.