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FDA 510(k)

MANUAL OPHTHALMIC SURGICAL INSTRUMENTS

K-Number: K861057 · 1986-04-24

ApplicantPrecision-Cosmet Co., Inc.
Decision Date1986-04-24
Product CodeHNR
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

MANUAL OPHTHALMIC SURGICAL INSTRUMENTS is the device name listed in this FDA 510(k) record. The listed applicant is Precision-Cosmet Co., Inc.. It received FDA 510(k) clearance on 1986-04-24 under 510(k) number K861057. 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 MANUAL OPHTHALMIC SURGICAL INSTRUMENTS?

MANUAL OPHTHALMIC SURGICAL INSTRUMENTS is a medical device that received FDA 510(k) clearance on 1986-04-24. The listed applicant is Precision-Cosmet Co., Inc.. The 510(k) number is K861057.

When did MANUAL OPHTHALMIC SURGICAL INSTRUMENTS receive FDA 510(k) clearance?

MANUAL OPHTHALMIC SURGICAL INSTRUMENTS received FDA 510(k) clearance on 1986-04-24, under 510(k) number K861057.

Who is the listed applicant for MANUAL OPHTHALMIC SURGICAL INSTRUMENTS?

The FDA 510(k) record lists Precision-Cosmet Co., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MANUAL OPHTHALMIC SURGICAL INSTRUMENTS?

The FDA product code for MANUAL OPHTHALMIC SURGICAL INSTRUMENTS is HNR.

Related Clinical Trials

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Other records listing Precision-Cosmet Co., 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.

K852934PRECISION - COSMET CAPSULE COUPEURK840204WHITE OCULAR PRESSURE RELIEF DEVICEK840104PETRUS IOL GUIDE

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 LaboratoriesK881049BRADBURY INTRAOCULAR RETINAL KIT CAT #200Microline Pentax, 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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