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FDA 510(k)

POLYDERM WBC (TM), WATERPROOF BREATHABLE COVER

K-Number: K880206 · 1988-03-11

ApplicantLaivan Corp.
Decision Date1988-03-11
Product CodeNAD
Advisory CommitteeSU
DecisionSubstantially Equivalent for Some Indications

Device Summary

POLYDERM WBC (TM), WATERPROOF BREATHABLE 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 1988-03-11 under 510(k) number K880206. 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 WBC (TM), WATERPROOF BREATHABLE COVER?

POLYDERM WBC (TM), WATERPROOF BREATHABLE COVER is a medical device that received FDA 510(k) clearance on 1988-03-11. The listed applicant is Laivan Corp.. The 510(k) number is K880206.

When did POLYDERM WBC (TM), WATERPROOF BREATHABLE COVER receive FDA 510(k) clearance?

POLYDERM WBC (TM), WATERPROOF BREATHABLE COVER received FDA 510(k) clearance on 1988-03-11, under 510(k) number K880206.

Who is the listed applicant for POLYDERM WBC (TM), WATERPROOF BREATHABLE 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 WBC (TM), WATERPROOF BREATHABLE COVER?

The FDA product code for POLYDERM WBC (TM), WATERPROOF BREATHABLE COVER 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)K885205AQUADERMK880153POLYDERM A+B(TM)K880964POLYDERM PEC(TM), POROUS ELASTIC 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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