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FDA 510(k)

REUSABLE SURGICAL KERATOSCOPE

K-Number: K864639 · 1986-12-29

ApplicantJedmed Instrument Co.
Decision Date1986-12-29
Product CodeHLR
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

REUSABLE SURGICAL KERATOSCOPE is the device name listed in this FDA 510(k) record. The listed applicant is Jedmed Instrument Co.. It received FDA 510(k) clearance on 1986-12-29 under 510(k) number K864639. The device is classified under product code HLR. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the REUSABLE SURGICAL KERATOSCOPE?

REUSABLE SURGICAL KERATOSCOPE is a medical device that received FDA 510(k) clearance on 1986-12-29. The listed applicant is Jedmed Instrument Co.. The 510(k) number is K864639.

When did REUSABLE SURGICAL KERATOSCOPE receive FDA 510(k) clearance?

REUSABLE SURGICAL KERATOSCOPE received FDA 510(k) clearance on 1986-12-29, under 510(k) number K864639.

Who is the listed applicant for REUSABLE SURGICAL KERATOSCOPE?

The FDA 510(k) record lists Jedmed Instrument Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for REUSABLE SURGICAL KERATOSCOPE?

The FDA product code for REUSABLE SURGICAL KERATOSCOPE is HLR.

Related Clinical Trials

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Other records listing Jedmed Instrument Co. 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.

K021750LID CHAIN EYELID WEIGHTSK954184JED-LIGHT FIBEROPTIC LIGHT SOURCEK944032VIDEO SCOPE SYSTEM (LARYNGOSCOPE)K953457JEDMED SPECTRUM ENT CABINETK950925JEDMED LARYNGEAL SCOPEK950785HORTMANN AIRMATIC AIR CALORIC STIMULATOR

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Related Devices (Code: HLR)

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.

K901553SURG-K SURGICAL KERATOMETERThe Sanborn Co.K882902QRK 100, QUALITATIVE RING KERATOSCOPETechnitex, Inc.K882618JEDMED/POLACK KERATOSCOPE HS/SLGamut Ent.K854054PLACIDO DISCCutler Medical InstrumentsK830008KARICKHOFF KERATOSCOPESurgidev Corp.K821080HAND KERATOSCOPEMedical Equipment Designs, 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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