PENILE CONSTRICTOR RING— 510(k) K001859

Substantially Equivalent

Basic Solutions, LLC

FDA 510(k) clearance K001859 for PENILE CONSTRICTOR RING, Substantially Equivalent on 2001-01-11. Applicant: Basic Solutions, LLC. Device class: 2.

Clearance details

Applicant: Basic Solutions, LLC
Product code: Code LKY
Device class: Class 2
Regulation: 21 CFR 876.5020
Advisory panel: Gastroenterology, Urology
Date received: 2000-06-19
Decision date: 2001-01-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Monica, CA, US

Download summary PDF View on FDA.gov ↗

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K032776 — VACURECT VACUUM CONSTRICTION DEVICE2003-10-03
K030119 — NANMA ADJUSTABLE CONSTRICTION RING2003-08-06
K030913 — NANMA VACUUM PUMP2003-06-03
K013113 — MODIFICATION TO NANMA VACUUM PUMP2002-12-20

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