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FDA 510(k)

BRADBURY INTRAOCULAR RETINAL KIT CAT #200

K-Number: K881049 · 1988-09-12

ApplicantMicroline Pentax, Inc.
Decision Date1988-09-12
Product CodeHNR
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

BRADBURY INTRAOCULAR RETINAL KIT CAT #200 is the device name listed in this FDA 510(k) record. The listed applicant is Microline Pentax, Inc.. It received FDA 510(k) clearance on 1988-09-12 under 510(k) number K881049. The device is classified under product code HNR. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BRADBURY INTRAOCULAR RETINAL KIT CAT #200?

BRADBURY INTRAOCULAR RETINAL KIT CAT #200 is a medical device that received FDA 510(k) clearance on 1988-09-12. The listed applicant is Microline Pentax, Inc.. The 510(k) number is K881049.

When did BRADBURY INTRAOCULAR RETINAL KIT CAT #200 receive FDA 510(k) clearance?

BRADBURY INTRAOCULAR RETINAL KIT CAT #200 received FDA 510(k) clearance on 1988-09-12, under 510(k) number K881049.

Who is the listed applicant for BRADBURY INTRAOCULAR RETINAL KIT CAT #200?

The FDA 510(k) record lists Microline Pentax, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BRADBURY INTRAOCULAR RETINAL KIT CAT #200?

The FDA product code for BRADBURY INTRAOCULAR RETINAL KIT CAT #200 is HNR.

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Other records listing Microline Pentax, 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.

K013695MICROLINE INC. REUSABLE LAPAROSCOPIC CLIP APPLIER WITH IMPLANTABLE TITANIUM CLIPS, MODEL M/L-10K982984ACCUSHEAR LAPAROSCOPIC SURGICAL INSTRUMENTSK981389DISPOSABLE RE-NEW FORCEPSK981188ELECTROSURGICAL CAUTERY PROBESK9807583 MM SELEC-TIP LAPAROSCOPIC SCISSORSK974066RE-NEW FORCEPS LAPAROSCOPIC SURGICAL TIPS

View all 12 devices →

Related Devices (Code: HNR)

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.

K022835STEPHENS DISPOSABLE FORCEPSStephens InstrumentsK895434ALCON FOLDING FORCEPSAlcon LaboratoriesK891487SOFT LENS FOLDING BLOCKWestern Medical Products, Inc.K893199PHACO-INJECTOR(TM) INTRAOCULAR LENS IMPLANT INSTRAllergan Medical OpticsK885230MCDONALD FOLDING FORCEPSAlcon LaboratoriesK883197IOL IMPLANTATION FORCEPSD & D Surgical

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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