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FDA 510(k)

CHEM-SLEEVE B

K-Number: K912257 · 1991-12-31

ApplicantHaz-Med, Inc.
Decision Date1991-12-31
Product CodeKME
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

CHEM-SLEEVE B 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 1991-12-31 under 510(k) number K912257. 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 B?

CHEM-SLEEVE B is a medical device that received FDA 510(k) clearance on 1991-12-31. The listed applicant is Haz-Med, Inc.. The 510(k) number is K912257.

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

CHEM-SLEEVE B received FDA 510(k) clearance on 1991-12-31, under 510(k) number K912257.

Who is the listed applicant for CHEM-SLEEVE B?

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 B?

The FDA product code for CHEM-SLEEVE B 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.

K901509TRAUMA SLEEVEK901629CHEM-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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