INFUSION HANDLE— 510(k) K881518

Substantially Equivalent

B&B Medical Assoc., Inc.

FDA 510(k) clearance K881518 for INFUSION HANDLE, Substantially Equivalent on 1988-08-22. Applicant: B&B Medical Assoc., Inc.. Device class: 1.

Clearance details

Applicant: B&B Medical Assoc., Inc.
Product code: Code KYG
Device class: Class 1
Regulation: 21 CFR 886.4360
Advisory panel: Ophthalmic
Date received: 1988-04-11
Decision date: 1988-08-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Danvers, MA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KYG

K010353 — MED-LOGICS DISPOSABLE ALK TUBING2001-04-27
K003036 — TURBO-FLOW INFUSION CANNULA 19 GAGE,20 GAGE,23 GAGE, 25 GAGE, MODEL 101019,101020,101023,1010252000-12-22
K993591 — BLADEWORKS DISPOSABLE ALK TUBING1999-12-28
K981116 — SOVEREIGN CATARACT EXTRACTION SYSTEM1998-05-19
K980647 — EYE IRRIGATOR MODEL #20201998-05-15

More clearances from B&B Medical Assoc., Inc.

K881707 — INTROCULAR FLUID INJECTOR1988-10-21
K881519 — VAC-G (GUILLOTINE VITRECTOR)1988-09-08
K881520 — VAC (OSCILLATING VITRECTOR)1988-09-07
K881517 — B & B I/A HANDPIECE1988-08-22

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