ERECTION DEVICE— 510(k) K896061

Substantially Equivalent

Clyde Engineering Service

FDA 510(k) clearance K896061 for ERECTION DEVICE, Substantially Equivalent on 1990-03-07. Applicant: Clyde Engineering Service. Device class: 2.

Clearance details

Applicant: Clyde Engineering Service
Product code: Code LKY
Device class: Class 2
Regulation: 21 CFR 876.5020
Advisory panel: Gastroenterology, Urology
Date received: 1989-10-18
Decision date: 1990-03-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: New Orleans, LA, 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.