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FDA 510(k)

I.M. SCALPEL HANDLE

K-Number: K810720 · 1981-04-03

ApplicantInstrument Makar, Inc.
Decision Date1981-04-03
Product CodeGDZ
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

I.M. SCALPEL HANDLE 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 1981-04-03 under 510(k) number K810720. The device is classified under product code GDZ. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the I.M. SCALPEL HANDLE?

I.M. SCALPEL HANDLE is a medical device that received FDA 510(k) clearance on 1981-04-03. The listed applicant is Instrument Makar, Inc.. The 510(k) number is K810720.

When did I.M. SCALPEL HANDLE receive FDA 510(k) clearance?

I.M. SCALPEL HANDLE received FDA 510(k) clearance on 1981-04-03, under 510(k) number K810720.

Who is the listed applicant for I.M. SCALPEL HANDLE?

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 I.M. SCALPEL HANDLE?

The FDA product code for I.M. SCALPEL HANDLE is GDZ.

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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: GDZ)

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.

K091462SPECTRA MEDICAL SAFETY SCAPELSpectra, Inc.K890242SCALPEL HANDLEKinetic Medical ProductsK884512BEAVER(R) HANDLEBd Becton Dickinson Vacutainer Systems PreanalyticK863951P.S.I.-DISPOSABLE SCALPEL SURGEONS HANDLEPrecision Surgical Industries, Inc.K863808THE S. CORDERO STYLUSS. Cordero Co.K863212KEISEI HANDLES FOR SURGICAL BLADESKeisei Medical Industrial Co., Ltd.

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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