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FDA 510(k)

CHEM-SLEEVE

K-Number: K901629 · 1990-04-27

ApplicantHaz-Med, Inc.
Decision Date1990-04-27
Product CodeKME
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

CHEM-SLEEVE is the device name listed in this FDA 510(k) record. The listed applicant is Haz-Med, Inc.. It received FDA 510(k) clearance on 1990-04-27 under 510(k) number K901629. The device is classified under product code KME. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CHEM-SLEEVE?

CHEM-SLEEVE is a medical device that received FDA 510(k) clearance on 1990-04-27. The listed applicant is Haz-Med, Inc.. The 510(k) number is K901629.

When did CHEM-SLEEVE receive FDA 510(k) clearance?

CHEM-SLEEVE received FDA 510(k) clearance on 1990-04-27, under 510(k) number K901629.

Who is the listed applicant for CHEM-SLEEVE?

The FDA 510(k) record lists Haz-Med, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CHEM-SLEEVE?

The FDA product code for CHEM-SLEEVE is KME.

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 Haz-Med, 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.

K912257CHEM-SLEEVE BK901509TRAUMA SLEEVE

Related Devices (Code: KME)

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.

K042145READY-HEAT BLANKETTechtrade, LLCK944953OREX MEDICAL BEDDINGThantex Specialties, Inc.K933636DISPOSE-A-SHEETBelmac Healthcare Corp.K932539DOCTOR DOWN --RESCUE WRAPThree Dog DownK922143AMERICAN BURN SHEETAmerican Silk Sutures, Inc.K915303FOIL BABY BUNTINGGam Industries, Inc.

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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