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FDA 510(k)

AMERIGEL WOUND DRESSING PLUS 1/2 OZ. (15G TUBE), MODEL A2025; 1 OZ. (30G TUBE), MODEL A2026; 3 OZ (90G TUBE),MODEL A2027

K-Number: K092086 · 2009-07-30

ApplicantAmerx Health Care Corp.
Decision Date2009-07-30
Product CodeSEJ
DecisionSubstantially Equivalent

Device Summary

AMERIGEL WOUND DRESSING PLUS 1/2 OZ. (15G TUBE), MODEL A2025; 1 OZ. (30G TUBE), MODEL A2026; 3 OZ (90G TUBE),MODEL A2027 is the device name listed in this FDA 510(k) record. The listed applicant is Amerx Health Care Corp.. It received FDA 510(k) clearance on 2009-07-30 under 510(k) number K092086. The device is classified under product code SEJ. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AMERIGEL WOUND DRESSING PLUS 1/2 OZ. (15G TUBE), MODEL A2025; 1 OZ. (30G TUBE), MODEL A2026; 3 OZ (90G TUBE),MODEL A2027?

AMERIGEL WOUND DRESSING PLUS 1/2 OZ. (15G TUBE), MODEL A2025; 1 OZ. (30G TUBE), MODEL A2026; 3 OZ (90G TUBE),MODEL A2027 is a medical device that received FDA 510(k) clearance on 2009-07-30. The listed applicant is Amerx Health Care Corp.. The 510(k) number is K092086.

When did AMERIGEL WOUND DRESSING PLUS 1/2 OZ. (15G TUBE), MODEL A2025; 1 OZ. (30G TUBE), MODEL A2026; 3 OZ (90G TUBE),MODEL A2027 receive FDA 510(k) clearance?

AMERIGEL WOUND DRESSING PLUS 1/2 OZ. (15G TUBE), MODEL A2025; 1 OZ. (30G TUBE), MODEL A2026; 3 OZ (90G TUBE),MODEL A2027 received FDA 510(k) clearance on 2009-07-30, under 510(k) number K092086.

Who is the listed applicant for AMERIGEL WOUND DRESSING PLUS 1/2 OZ. (15G TUBE), MODEL A2025; 1 OZ. (30G TUBE), MODEL A2026; 3 OZ (90G TUBE),MODEL A2027?

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

What is the FDA product code for AMERIGEL WOUND DRESSING PLUS 1/2 OZ. (15G TUBE), MODEL A2025; 1 OZ. (30G TUBE), MODEL A2026; 3 OZ (90G TUBE),MODEL A2027?

The FDA product code for AMERIGEL WOUND DRESSING PLUS 1/2 OZ. (15G TUBE), MODEL A2025; 1 OZ. (30G TUBE), MODEL A2026; 3 OZ (90G TUBE),MODEL A2027 is SEJ.

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 Amerx Health Care 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.

K971918AMERIGEL OINTMENT SATURATED WOUND DRESSINGK970133AMERIGEL OINTMENT

Related Devices (Code: SEJ)

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.

K053476ALLWOUNDAt Squared, LLCK020540REGENECARE WOUND GELMpm Medical., Inc.K001023FREEDOM, MODEL 4660Johnson & Johnson Consumer Companies, Inc.K922636HEMO-STATMckinley-Ross Laboratories, Inc.K912565MICRO-COLL COLLAGEN WOUND SPRAYMicro-Coll

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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