MAXERECT— 510(k) K881008

Substantially Equivalent

Kenneth Chapman

FDA 510(k) clearance K881008 for MAXERECT, Substantially Equivalent on 1988-10-12. Applicant: Kenneth Chapman. Device class: 2.

Clearance details

Applicant: Kenneth Chapman
Product code: Code LKY
Device class: Class 2
Regulation: 21 CFR 876.5020
Advisory panel: Gastroenterology, Urology
Date received: 1988-03-09
Decision date: 1988-10-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bellaire, TX, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LKY

K041573 — NANMA VACUUM PUMP PROXZEK MODEL 2M9498S2004-08-25
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.