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FDA 510(k)

HEDLEYL INTRAMEDULLARY PREPARATION BRUSH

K-Number: K931737 · 1994-01-07

ApplicantSynvasive Technology, Inc.
Decision Date1994-01-07
Product CodeHTZ
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

HEDLEYL INTRAMEDULLARY PREPARATION BRUSH is the device name listed in this FDA 510(k) record. The listed applicant is Synvasive Technology, Inc.. It received FDA 510(k) clearance on 1994-01-07 under 510(k) number K931737. The device is classified under product code HTZ. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HEDLEYL INTRAMEDULLARY PREPARATION BRUSH?

HEDLEYL INTRAMEDULLARY PREPARATION BRUSH is a medical device that received FDA 510(k) clearance on 1994-01-07. The listed applicant is Synvasive Technology, Inc.. The 510(k) number is K931737.

When did HEDLEYL INTRAMEDULLARY PREPARATION BRUSH receive FDA 510(k) clearance?

HEDLEYL INTRAMEDULLARY PREPARATION BRUSH received FDA 510(k) clearance on 1994-01-07, under 510(k) number K931737.

Who is the listed applicant for HEDLEYL INTRAMEDULLARY PREPARATION BRUSH?

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

What is the FDA product code for HEDLEYL INTRAMEDULLARY PREPARATION BRUSH?

The FDA product code for HEDLEYL INTRAMEDULLARY PREPARATION BRUSH is HTZ.

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Related Devices (Code: HTZ)

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.

K933933CEBOPLANESynvasive Technology, Inc.K87088245 DEGREE SHAVERBowen & Company, Inc.K853678KAMBIN SPINAL INSTRUMENT SETPilling Co.K850527ARTHROSCOPY SUCTION BIOPSY PUNCHT. Korossurgical Instruments Corp.K850423CONCEPT SUCTION SLEEVEConcept, Inc.K841980SIDE CUTTING SERRATED BLADEStainless Mfg., 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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