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FDA 510(k)

FISCH DRILL IRRIGATOR

K-Number: K861298 · 1986-04-23

ApplicantJedmed Instrument Co.
Decision Date1986-04-23
Product CodeKAR
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

FISCH DRILL IRRIGATOR 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 1986-04-23 under 510(k) number K861298. The device is classified under product code KAR. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FISCH DRILL IRRIGATOR?

FISCH DRILL IRRIGATOR is a medical device that received FDA 510(k) clearance on 1986-04-23. The listed applicant is Jedmed Instrument Co.. The 510(k) number is K861298.

When did FISCH DRILL IRRIGATOR receive FDA 510(k) clearance?

FISCH DRILL IRRIGATOR received FDA 510(k) clearance on 1986-04-23, under 510(k) number K861298.

Who is the listed applicant for FISCH DRILL IRRIGATOR?

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 FISCH DRILL IRRIGATOR?

The FDA product code for FISCH DRILL IRRIGATOR is KAR.

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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)K950925JEDMED LARYNGEAL SCOPEK953457JEDMED SPECTRUM ENT CABINETK950785HORTMANN AIRMATIC AIR CALORIC STIMULATOR

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Related Devices (Code: KAR)

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.

K131177SINUFLUSH LAVAGE SYSTEMHedgepath, LLCK931398GM SWIVEL VIDEO (TM) IRRIGATORGm Engineering, 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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