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FDA 510(k)

FLORASEAL, MODEL FS350D

K-Number: K083354 · 2009-07-20

ApplicantAdhezion Biomedical
Decision Date2009-07-20
Product CodeNZP
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

FLORASEAL, MODEL FS350D is the device name listed in this FDA 510(k) record. The listed applicant is Adhezion Biomedical. It received FDA 510(k) clearance on 2009-07-20 under 510(k) number K083354. The device is classified under product code NZP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FLORASEAL, MODEL FS350D?

FLORASEAL, MODEL FS350D is a medical device that received FDA 510(k) clearance on 2009-07-20. The listed applicant is Adhezion Biomedical. The 510(k) number is K083354.

When did FLORASEAL, MODEL FS350D receive FDA 510(k) clearance?

FLORASEAL, MODEL FS350D received FDA 510(k) clearance on 2009-07-20, under 510(k) number K083354.

Who is the listed applicant for FLORASEAL, MODEL FS350D?

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

What is the FDA product code for FLORASEAL, MODEL FS350D?

The FDA product code for FLORASEAL, MODEL FS350D is NZP.

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 Adhezion Biomedical 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.

K082993SURGISEAL TOPICAL SKIN ADHESIVE

Related Devices (Code: NZP)

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.

K223669SecurePortIV Advanced Catheter Securement AdhesiveAdhezion Biomedical, LLCK170505SecurePortIV Catheter Securement AdhesiveAdhezion Biomedical, LLCK052870INTEGUSEAL MICROBIAL SEALANT, MODEL IS 100 AND 1S200Kimberly-Clark Corp.

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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