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510(k) K881517

B & B I/A HANDPIECE by B&B Medical Assoc., Inc. — Product Code KYG

K881517 is an FDA 510(k) premarket notification submitted by B&B Medical Assoc., Inc. for the device "B & B I/A HANDPIECE". The FDA issued a decision of Substantially Equivalent on August 22, 1988. The device falls under product code KYG (Device, Irrigation, Ocular Surgery), a Class I device regulated under 21 CFR 886.4360. B&B Medical Assoc., Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 22, 1988
Date Received
April 11, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Irrigation, Ocular Surgery
Device Class
Class I
Regulation Number
886.4360
Review Panel
OP
Submission Type

Other clearances by B&B Medical Assoc., Inc.

  • K881707 — INTROCULAR FLUID INJECTOR (October 21, 1988)
  • K881519 — VAC-G (GUILLOTINE VITRECTOR) (September 8, 1988)
  • K881520 — VAC (OSCILLATING VITRECTOR) (September 7, 1988)
  • K881518 — INFUSION HANDLE (August 22, 1988)

Other clearances for product code KYG

  • K010353 — MED-LOGICS DISPOSABLE ALK TUBING (April 27, 2001)
  • K003036 — TURBO-FLOW INFUSION CANNULA 19 GAGE,20 GAGE,23 GAGE, 25 GAGE, MODEL 101019,10102 (December 22, 2000)
  • K993591 — BLADEWORKS DISPOSABLE ALK TUBING (December 28, 1999)
  • K981116 — SOVEREIGN CATARACT EXTRACTION SYSTEM (May 19, 1998)
  • K980647 — EYE IRRIGATOR MODEL #2020 (May 15, 1998)
  • K974561 — MOISTAIR FLUID AIR TUBING SET (February 19, 1998)
  • K971173 — ML DISPOSABLE ALK TUBING (May 22, 1997)
  • K970161 — HEDGES CORNEAL WETTING PAK (March 25, 1997)
  • K954842 — D.O.R.C. VFI/VFE SYSTEM (April 15, 1996)
  • K945171 — DISPOSABLE & RESUABLE IRRIGATION/ASPIRATION HANDPIECE (February 8, 1995)

FDA data resources