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FDA 510(k)

TRAUMA SLEEVE

K-Number: K901509 · 1990-09-12

ApplicantHaz-Med, Inc.
Decision Date1990-09-12
Product CodeKME
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

TRAUMA 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 1990-09-12 under 510(k) number K901509. 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 TRAUMA SLEEVE?

TRAUMA SLEEVE is a medical device that received FDA 510(k) clearance on 1990-09-12. The listed applicant is Haz-Med, Inc.. The 510(k) number is K901509.

When did TRAUMA SLEEVE receive FDA 510(k) clearance?

TRAUMA SLEEVE received FDA 510(k) clearance on 1990-09-12, under 510(k) number K901509.

Who is the listed applicant for TRAUMA 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 TRAUMA SLEEVE?

The FDA product code for TRAUMA 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.

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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 BK901629CHEM-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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