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FDA 510(k)

INSTRUMENT MAKAR DISPOSALBE LOOP

K-Number: K853597 · 1985-09-23

ApplicantInstrument Makar, Inc.
Decision Date1985-09-23
Product CodeKDC
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

INSTRUMENT MAKAR DISPOSALBE LOOP is the device name listed in this FDA 510(k) record. The listed applicant is Instrument Makar, Inc.. It received FDA 510(k) clearance on 1985-09-23 under 510(k) number K853597. The device is classified under product code KDC. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INSTRUMENT MAKAR DISPOSALBE LOOP?

INSTRUMENT MAKAR DISPOSALBE LOOP is a medical device that received FDA 510(k) clearance on 1985-09-23. The listed applicant is Instrument Makar, Inc.. The 510(k) number is K853597.

When did INSTRUMENT MAKAR DISPOSALBE LOOP receive FDA 510(k) clearance?

INSTRUMENT MAKAR DISPOSALBE LOOP received FDA 510(k) clearance on 1985-09-23, under 510(k) number K853597.

Who is the listed applicant for INSTRUMENT MAKAR DISPOSALBE LOOP?

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

What is the FDA product code for INSTRUMENT MAKAR DISPOSALBE LOOP?

The FDA product code for INSTRUMENT MAKAR DISPOSALBE LOOP is KDC.

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Other records listing Instrument Makar, 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.

K002600LITWIN CRUICATE ANCHORK980999ST LEGER CEMENTED SEMI-CONSTRAINED TOTAL KNEE IMPLANTK963396BIOSPHERE SUTURE ANCHORK964364DISPOSABLE APRONK955835FLUID BARRIER BOOT KNEE & ANKLE-HIGHK960555BIOASBSORBABLE MINI-SCREW SUTURE ANCHOR

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Related Devices (Code: KDC)

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.

K943229DISPOSABLE SURGICAL SCISSORS AND FORCEPSY.M.K. International Co., Ltd.K936226SURGIMED BREAST LOCALIZATION NEEDLE WIRE SETMeadox Medicals, Div. Boston Scientific Corp.K920153THERMUFF BAGTechstylesK920263MANUAL SURGICAL INSTRUMENTSPhoenix Instruments Div.K915064DISPOSABLE CAUTERY ABRASIVE PADAmerican Medical Mfg., Inc.K914960INSTRUMENT ORGANIZERO.R. Concepts, 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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