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FDA 510(k)

CHERMEL OSTEOTOMES

K-Number: K842823 · 1984-08-02

ApplicantCher Mel Corp.
Decision Date1984-08-02
Product CodeGFI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

CHERMEL OSTEOTOMES is the device name listed in this FDA 510(k) record. The listed applicant is Cher Mel Corp.. It received FDA 510(k) clearance on 1984-08-02 under 510(k) number K842823. The device is classified under product code GFI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CHERMEL OSTEOTOMES?

CHERMEL OSTEOTOMES is a medical device that received FDA 510(k) clearance on 1984-08-02. The listed applicant is Cher Mel Corp.. The 510(k) number is K842823.

When did CHERMEL OSTEOTOMES receive FDA 510(k) clearance?

CHERMEL OSTEOTOMES received FDA 510(k) clearance on 1984-08-02, under 510(k) number K842823.

Who is the listed applicant for CHERMEL OSTEOTOMES?

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

What is the FDA product code for CHERMEL OSTEOTOMES?

The FDA product code for CHERMEL OSTEOTOMES is GFI.

Related Clinical Trials

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.

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Other records listing Cher Mel 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.

K863040DISPOSABLE INTRAVENOUS HYPERALIMENTATION BAGSK851516CHERMEL SCALP VEIN SETK843324SPRAGUE RAPPAPORT/SH-6008 DISPOS. STETHK842203LITTMAN TYPE SH-6010, NURSE TYPEK842822CHERMEL BONE GOUGESK842824CHERMEL BONE CHISELS

View all 7 devices →

Related Devices (Code: GFI)

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.

K933181VALLEYLAB FORCE GSU HANDSET ADAPTER MODEL #E0500Valleylab, Inc.K932534ISI FENESTRATED DISSECTING AND GRASPING FORCEPSInnovative Surgical, Inc.K920001HEMOLAB SILIMAT REAGENTBiomerieux Vitek, Inc.K891887OSTEOTOMES, VARIOUS TYPESZinnanti Surgical Instruments, Inc.K852541STORZ ION BOND OSTEOTOMES & RASPS, FAST CU BURSStorz Instrument Co.

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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