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FDA 510(k)

(MICRO-KERATRON, MICRO DUCT TREPHINE)

K-Number: K791763 · 1979-11-05

ApplicantIntl. Ophthalmic Industries Corp.
Decision Date1979-11-05
Product CodeHRG
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

(MICRO-KERATRON, MICRO DUCT TREPHINE) is the device name listed in this FDA 510(k) record. The listed applicant is Intl. Ophthalmic Industries Corp.. It received FDA 510(k) clearance on 1979-11-05 under 510(k) number K791763. The device is classified under product code HRG. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the (MICRO-KERATRON, MICRO DUCT TREPHINE)?

(MICRO-KERATRON, MICRO DUCT TREPHINE) is a medical device that received FDA 510(k) clearance on 1979-11-05. The listed applicant is Intl. Ophthalmic Industries Corp.. The 510(k) number is K791763.

When did (MICRO-KERATRON, MICRO DUCT TREPHINE) receive FDA 510(k) clearance?

(MICRO-KERATRON, MICRO DUCT TREPHINE) received FDA 510(k) clearance on 1979-11-05, under 510(k) number K791763.

Who is the listed applicant for (MICRO-KERATRON, MICRO DUCT TREPHINE)?

The FDA 510(k) record lists Intl. Ophthalmic Industries Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for (MICRO-KERATRON, MICRO DUCT TREPHINE)?

The FDA product code for (MICRO-KERATRON, MICRO DUCT TREPHINE) is HRG.

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Other records listing Intl. Ophthalmic Industries Corp. 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.

K961658MEGATRON OPHTHALMIC SURGICAL SYSTEMK894513DIATHRON(R) DIATHERMY UNITK894512PHACOEMULSIFICATION UNIT TO REMOVE CATARAC. LENSK894511MAGNETRON MUNICH MODEL ELECTRONIC CONTROL UNITK823088ASPITRON

Related Devices (Code: HRG)

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.

K013151ASMOTOM AUTOMATED TREPHINE SYSTEMBkg Opthalmics USA, Inc.K981063AUTOMATED CORNEAL TREPHINELaser Center Dev. Corp.K843957ULTRATHIN/SP LENSOptical Systems Intl., Inc.K841515SCANLAN VASCU-STATT IIScanlan Intl., Inc.K823901TREPHINE BLADES-VARIOUS MODELSEdward Weck, 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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