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FDA 510(k)

SEPRAGEL ENT BIORESORBABLE PACKING/STENT

K-Number: K043035 · 2005-07-11

ApplicantGenzyme Corporation
Decision Date2005-07-11
Product CodeKHJ
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

SEPRAGEL ENT BIORESORBABLE PACKING/STENT is the device name listed in this FDA 510(k) record. The listed applicant is Genzyme Corporation. It received FDA 510(k) clearance on 2005-07-11 under 510(k) number K043035. The device is classified under product code KHJ. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SEPRAGEL ENT BIORESORBABLE PACKING/STENT?

SEPRAGEL ENT BIORESORBABLE PACKING/STENT is a medical device that received FDA 510(k) clearance on 2005-07-11. The listed applicant is Genzyme Corporation. The 510(k) number is K043035.

When did SEPRAGEL ENT BIORESORBABLE PACKING/STENT receive FDA 510(k) clearance?

SEPRAGEL ENT BIORESORBABLE PACKING/STENT received FDA 510(k) clearance on 2005-07-11, under 510(k) number K043035.

Who is the listed applicant for SEPRAGEL ENT BIORESORBABLE PACKING/STENT?

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

What is the FDA product code for SEPRAGEL ENT BIORESORBABLE PACKING/STENT?

The FDA product code for SEPRAGEL ENT BIORESORBABLE PACKING/STENT is KHJ.

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Other records listing Genzyme Corporation 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.

K102242OSOM C. DIFFICILE TOXIN A/B TESTK092633OSOM INFLUENZA A&B TEST , MODEL PN190K080662GENZYME CYSTATIN C REAGENT ANF GENZYME CYSTATIN C CALIBRATORK063739SEPRAMESH, MODEL 5959-1214K053066SEPRAMESH IP BIORESORBABLE COATING/PERMANENT MESH

Related Devices (Code: KHJ)

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.

K260266Tympendi™ (810)Grace Medical, Inc.K232646Biodesign Otologic Butterfly Graft (ENT-OTO-BFLY-0.4-0.6); Biodesign Otologic Butterfly Graft (ENT-OTO-BFLY-0.6-0.9)Cook Biotech IncorporatedK161000Biodesign Otologic Repair GraftCook Biotech IncorporatedK132198ADAPTAIN, ADAPTAIN FASTWRAP, ENVELOCK, BIOWAICeremed , Inc.K121360BIODESIGN ENT REPAIR GRAFTCook Biotech IncorpratedK122561ADAPTAIN FASTWRAP, ENVELOCK, GRAFTAINCeremed , Inc.

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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