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FDA 510(k)

STERILE BARRIER SLEEVE AND COVER

K-Number: K930552 · 1994-07-05

ApplicantPatient Safety Products, Inc.
Decision Date1994-07-05
Product CodeMMP
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

STERILE BARRIER SLEEVE AND COVER is the device name listed in this FDA 510(k) record. The listed applicant is Patient Safety Products, Inc.. It received FDA 510(k) clearance on 1994-07-05 under 510(k) number K930552. The device is classified under product code MMP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STERILE BARRIER SLEEVE AND COVER?

STERILE BARRIER SLEEVE AND COVER is a medical device that received FDA 510(k) clearance on 1994-07-05. The listed applicant is Patient Safety Products, Inc.. The 510(k) number is K930552.

When did STERILE BARRIER SLEEVE AND COVER receive FDA 510(k) clearance?

STERILE BARRIER SLEEVE AND COVER received FDA 510(k) clearance on 1994-07-05, under 510(k) number K930552.

Who is the listed applicant for STERILE BARRIER SLEEVE AND COVER?

The FDA 510(k) record lists Patient Safety Products, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for STERILE BARRIER SLEEVE AND COVER?

The FDA product code for STERILE BARRIER SLEEVE AND COVER is MMP.

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

Related Devices (Code: MMP)

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.

K091178MTP DISPOSABLE EQUIPMENT COVERS, KARL STORZ 15 TOUCH SCREENMtp Medical Technical Promotion GmbHK043234LIGHT DRAPEWrapped IN ComfortK041501GUANGZHOU FORTUNIQUE DRAPES, BAGS AND COVERSGuangzhou Fortunique , Ltd.K040794INCUBATOR CAPEWrapped IN ComfortK032065MEDLINE BAND BAGS AND EQUIPMENT COVERSMedline Industries, Inc.K023540SNAP KOVER, MODEL 01-2020; SNAP KAPS, MODEL 03-KP09Valumed

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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