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FDA 510(k)

MEDSPEC OPERATIVE OPTHALMIC KIT

K-Number: K800404 · 1980-04-24

ApplicantMedi-Spec
Decision Date1980-04-24
Product CodeHMP
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MEDSPEC OPERATIVE OPTHALMIC KIT is the device name listed in this FDA 510(k) record. The listed applicant is Medi-Spec. It received FDA 510(k) clearance on 1980-04-24 under 510(k) number K800404. The device is classified under product code HMP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MEDSPEC OPERATIVE OPTHALMIC KIT?

MEDSPEC OPERATIVE OPTHALMIC KIT is a medical device that received FDA 510(k) clearance on 1980-04-24. The listed applicant is Medi-Spec. The 510(k) number is K800404.

When did MEDSPEC OPERATIVE OPTHALMIC KIT receive FDA 510(k) clearance?

MEDSPEC OPERATIVE OPTHALMIC KIT received FDA 510(k) clearance on 1980-04-24, under 510(k) number K800404.

Who is the listed applicant for MEDSPEC OPERATIVE OPTHALMIC KIT?

The FDA 510(k) record lists Medi-Spec as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MEDSPEC OPERATIVE OPTHALMIC KIT?

The FDA product code for MEDSPEC OPERATIVE OPTHALMIC KIT is HMP.

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Other records listing Medi-Spec 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.

K833068LAMINARIA JAPONICA CERVICAL DILATORK812694WHISK-RK812426UTERINE ASPIRATION CURETTES(RIGID&FLEX)K801554STERILE CAST PADDINGK800490STERILE DRESSING PACKK790952CLAMP COVERS

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Related Devices (Code: HMP)

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.

K940333EYE PADCertified Safety Mfg., Inc.K921349STERILE,DISPOSABLE EYE DRESSINGDeroyal Industries, Inc.K904896EYE PADUlti-Med Intl., Inc.K883822FIRST AID KIT, EYE DRESSING NSN6545-00-853-6309Consolidated Industries of Greater Syracuse, Inc.K874411DONALDSON NATURAL EYEPATCH 'PATIENT PAK'Keeler Instruments, Inc.K864810LIDSPLINTPrecision Therapeutics, 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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