OPERAND LUBRICATING JELLY— 510(k) K912132

Substantially Equivalent

General Medical Co.

FDA 510(k) clearance K912132 for OPERAND LUBRICATING JELLY, Substantially Equivalent on 1991-08-07. Applicant: General Medical Co.. Device class: 2.

Clearance details

Applicant: General Medical Co.
Product code: Code FHX
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 1991-05-14
Decision date: 1991-08-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Prichard, WV, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code FHX

K081990 — LUBRICANO STERILE GEL2008-12-05
K951713 — BUTTON LUBRICATOR1995-04-25
K935548 — CATHEJELL S STERILE LUBRICATING JELLY1994-03-30
K780386 — K-Y LUBRICATING JELLY1978-04-13
K771364 — LUBE JEL1977-08-02

More clearances from General Medical Co.

K926269 — PROCEDURE KIT1993-08-27
K912975 — OPERAND LUBRICATING JELLY1991-09-27
K903669 — GENESIS INSUFFLATING CATHETER1990-09-12
K900110 — OPERAND* LUBRICATING JELLY1990-05-02
K853635 — SUBDERM TM1985-12-20

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