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FDA 510(k)

POLYDERM PEC(TM), POROUS ELASTIC COVER

K-Number: K880964 · 1988-03-17

ApplicantLaivan Corp.
Decision Date1988-03-17
Product CodeKGX
Advisory CommitteeHO
DecisionSubstantially Equivalent for Some Indications

Device Summary

POLYDERM PEC(TM), POROUS ELASTIC COVER is the device name listed in this FDA 510(k) record. The listed applicant is Laivan Corp.. It received FDA 510(k) clearance on 1988-03-17 under 510(k) number K880964. The device is classified under product code KGX. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the POLYDERM PEC(TM), POROUS ELASTIC COVER?

POLYDERM PEC(TM), POROUS ELASTIC COVER is a medical device that received FDA 510(k) clearance on 1988-03-17. The listed applicant is Laivan Corp.. The 510(k) number is K880964.

When did POLYDERM PEC(TM), POROUS ELASTIC COVER receive FDA 510(k) clearance?

POLYDERM PEC(TM), POROUS ELASTIC COVER received FDA 510(k) clearance on 1988-03-17, under 510(k) number K880964.

Who is the listed applicant for POLYDERM PEC(TM), POROUS ELASTIC COVER?

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 PEC(TM), POROUS ELASTIC COVER?

The FDA product code for POLYDERM PEC(TM), POROUS ELASTIC COVER is KGX.

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)K885205AQUADERMK880153POLYDERM A+B(TM)K880206POLYDERM WBC (TM), WATERPROOF BREATHABLE COVER

Related Devices (Code: KGX)

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.

K001240SERAGARD INJECTION PATCHPlatinum Services, Inc.K983368CARE BAND ANTIBACTERIAL BANDAGESAso Corp.K972914SYVEK PATCHMarine Polymer Technologies, Inc.K943314ADHESIVE BANDAGES WITH OTC DRUGJohnson & Johnson Consumer Products, Inc.K952606TARGETT PATCHCutting Edge Technologies, Inc.K954007PARALLELJohnson & Johnson Consumer Products, Inc.

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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