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FDA 510(k)

HYLASINE

K-Number: K993362 · 2000-03-13

ApplicantBiomatrix, Inc.
Decision Date2000-03-13
Product CodeEMX
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

HYLASINE is the device name listed in this FDA 510(k) record. The listed applicant is Biomatrix, Inc.. It received FDA 510(k) clearance on 2000-03-13 under 510(k) number K993362. The device is classified under product code EMX. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HYLASINE?

HYLASINE is a medical device that received FDA 510(k) clearance on 2000-03-13. The listed applicant is Biomatrix, Inc.. The 510(k) number is K993362.

When did HYLASINE receive FDA 510(k) clearance?

HYLASINE received FDA 510(k) clearance on 2000-03-13, under 510(k) number K993362.

Who is the listed applicant for HYLASINE?

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

What is the FDA product code for HYLASINE?

The FDA product code for HYLASINE is EMX.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Biomatrix, 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.

K994170HYLASHIELD CL

Related Devices (Code: EMX)

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.

K220326PosiSep X BAM Hemostat Dressing/Intranasal SplintHemostasis, LLCK041446NASALCEASELes Laboratorires Brothier, S.A.K000108RAPID RHINO-ANTERIOR 90MM, MODEL RR-A 90, RAPID RHINO-POSTERIOR 100MM, MODEL RR-P 100Bhk HoldingK983276HYDROFERA BACTERISTATIC NASAL DRESSINGHydrofera, LLCK982731MEROGEL NASAL DRESSING AND SINUS STENTXomed, Inc.K984069ENTAXIS NASAL PACKINGLes Laboratorires Brothier, S.A.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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