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510(k) K881707

INTROCULAR FLUID INJECTOR by B&B Medical Assoc., Inc. — Product Code FIH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 21, 1988
Date Received
April 11, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pump, Infusion Or Syringe, Extra-Luminal
Device Class
Class II
Regulation Number
876.5820
Review Panel
GU
Submission Type

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

  • K881519 — VAC-G (GUILLOTINE VITRECTOR) (September 8, 1988)
  • K881520 — VAC (OSCILLATING VITRECTOR) (September 7, 1988)
  • K881518 — INFUSION HANDLE (August 22, 1988)
  • K881517 — B & B I/A HANDPIECE (August 22, 1988)

Other clearances for product code FIH

  • K932055 — PERCUPUMP II (March 21, 1995)
  • K935461 — VECTOR AMBULATORY DRUG DELIVERY SYSTEM (April 28, 1994)
  • K931113 — CADD-TPN(TM) AMBULATORY INFUSION SYSTEM (April 28, 1994)
  • K900439 — SINGLE-USE, STERILE, PREFILLED SYRINGE, 60CC (February 15, 1990)