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FDA 510(k)

POLYDERM A+B(TM)

K-Number: K880153 · 1988-04-13

ApplicantLaivan Corp.
Decision Date1988-04-13
Product CodeNAD
Advisory CommitteeSU
DecisionSubstantially Equivalent for Some Indications

Device Summary

POLYDERM A+B(TM) is the device name listed in this FDA 510(k) record. The listed applicant is Laivan Corp.. It received FDA 510(k) clearance on 1988-04-13 under 510(k) number K880153. The device is classified under product code NAD. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the POLYDERM A+B(TM)?

POLYDERM A+B(TM) is a medical device that received FDA 510(k) clearance on 1988-04-13. The listed applicant is Laivan Corp.. The 510(k) number is K880153.

When did POLYDERM A+B(TM) receive FDA 510(k) clearance?

POLYDERM A+B(TM) received FDA 510(k) clearance on 1988-04-13, under 510(k) number K880153.

Who is the listed applicant for POLYDERM A+B(TM)?

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

What is the FDA product code for POLYDERM A+B(TM)?

The FDA product code for POLYDERM A+B(TM) is NAD.

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 Laivan 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.

K923815TOTAL PROTECTIVE BREATHEABLE SURGICAL GOWNSK890940MODIFIED LABELING FOR POLYDERM WBC(TM)K885205AQUADERMK880964POLYDERM PEC(TM), POROUS ELASTIC COVERK880206POLYDERM WBC (TM), WATERPROOF BREATHABLE COVER

Related Devices (Code: NAD)

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.

K254246LT Antibacterial Foam with Silver DressingZhejiang Longterm Medical Technology Co., Ltd.K102403SAM CHEST SEAL WITH VAVLE; SAM CHEST SEALSam Medical ProductsK091133APLION TOPICAL CARE SYSTEMAplion Medical,LlcK072560ENVELA (HYDROHESIVE OCCLUSIVE DRESSING)Teikoku Pharma USA, Inc.K080524CENTURION SORBAVIEW OTCTri-State Hospital Supply Corp.K060046DERMASTREAMEnzysurge , Ltd.

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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