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FDA 510(k)

SURGICAL APPAREL SHOE COVERS

K-Number: K831952 · 1983-07-12

ApplicantSudreca Surgical Dressings, Inc.
Decision Date1983-07-12
Product CodeBWP
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SURGICAL APPAREL SHOE COVERS is the device name listed in this FDA 510(k) record. The listed applicant is Sudreca Surgical Dressings, Inc.. It received FDA 510(k) clearance on 1983-07-12 under 510(k) number K831952. The device is classified under product code BWP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SURGICAL APPAREL SHOE COVERS?

SURGICAL APPAREL SHOE COVERS is a medical device that received FDA 510(k) clearance on 1983-07-12. The listed applicant is Sudreca Surgical Dressings, Inc.. The 510(k) number is K831952.

When did SURGICAL APPAREL SHOE COVERS receive FDA 510(k) clearance?

SURGICAL APPAREL SHOE COVERS received FDA 510(k) clearance on 1983-07-12, under 510(k) number K831952.

Who is the listed applicant for SURGICAL APPAREL SHOE COVERS?

The FDA 510(k) record lists Sudreca Surgical Dressings, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SURGICAL APPAREL SHOE COVERS?

The FDA product code for SURGICAL APPAREL SHOE COVERS is BWP.

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 Sudreca Surgical Dressings, Inc. 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.

K832173GAUZE SPONGE STERILEK832172GAUZE SPONGE X-RAY DETECTABLE-K832174GAUZE SPONGE NON-STERILE

Related Devices (Code: BWP)

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.

K880384KIMBERLY-CLARK X-TRA TRACTION IMPERVIOUS BOOTKimberly-Clark Corp.K812105ANOGO DISPOSABLE SHOE COVERAnago, 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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