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FDA 510(k)

INTROCULAR FLUID INJECTOR

K-Number: K881707 · 1988-10-21

ApplicantB&B Medical Assoc., Inc.
Decision Date1988-10-21
Product CodeFIH
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

INTROCULAR FLUID INJECTOR is the device name listed in this FDA 510(k) record. The listed applicant is B&B Medical Assoc., Inc.. It received FDA 510(k) clearance on 1988-10-21 under 510(k) number K881707. The device is classified under product code FIH. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INTROCULAR FLUID INJECTOR?

INTROCULAR FLUID INJECTOR is a medical device that received FDA 510(k) clearance on 1988-10-21. The listed applicant is B&B Medical Assoc., Inc.. The 510(k) number is K881707.

When did INTROCULAR FLUID INJECTOR receive FDA 510(k) clearance?

INTROCULAR FLUID INJECTOR received FDA 510(k) clearance on 1988-10-21, under 510(k) number K881707.

Who is the listed applicant for INTROCULAR FLUID INJECTOR?

The FDA 510(k) record lists B&B Medical Assoc., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for INTROCULAR FLUID INJECTOR?

The FDA product code for INTROCULAR FLUID INJECTOR is FIH.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Other records listing B&B Medical Assoc., Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K881519VAC-G (GUILLOTINE VITRECTOR)K881520VAC (OSCILLATING VITRECTOR)K881518INFUSION HANDLEK881517B & B I/A HANDPIECE

Related Devices (Code: FIH)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K932055PERCUPUMP IIE-Z-Em, Inc.K931113CADD-TPN(TM) AMBULATORY INFUSION SYSTEMPharmacia Deltec, Inc.K935461VECTOR AMBULATORY DRUG DELIVERY SYSTEMInfusion Technology Intl.K900439SINGLE-USE, STERILE, PREFILLED SYRINGE, 60CCL H M Ent., Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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