B & B I/A HANDPIECE— 510(k) K881517

Substantially Equivalent

B&B Medical Assoc., Inc.

FDA 510(k) clearance K881517 for B & B I/A HANDPIECE, 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

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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
K881518 — INFUSION HANDLE1988-08-22

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