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FDA 510(k)

HEMO-BARRIER

K-Number: K953500 · 1996-01-24

ApplicantAsia Dynamics, Inc.
Decision Date1996-01-24
Product CodeKMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

HEMO-BARRIER is the device name listed in this FDA 510(k) record. The listed applicant is Asia Dynamics, Inc.. It received FDA 510(k) clearance on 1996-01-24 under 510(k) number K953500. The device is classified under product code KMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HEMO-BARRIER?

HEMO-BARRIER is a medical device that received FDA 510(k) clearance on 1996-01-24. The listed applicant is Asia Dynamics, Inc.. The 510(k) number is K953500.

When did HEMO-BARRIER receive FDA 510(k) clearance?

HEMO-BARRIER received FDA 510(k) clearance on 1996-01-24, under 510(k) number K953500.

Who is the listed applicant for HEMO-BARRIER?

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

What is the FDA product code for HEMO-BARRIER?

The FDA product code for HEMO-BARRIER is KMF.

Related Clinical Trials

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Other records listing Asia Dynamics, 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.

K953501ADI STERILE GAUZE SPONGESK952924ADI CATHETER WITH VALVEK891160MIC NON-STERILE LATEX GLOVES

Related Devices (Code: KMF)

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.

K241916TearRepair Liquid Skin ProtectantOptmed, Inc.K182733Rochal Bioshield Silicone FilmRochal Industries, LLCK171148Aleo BME Liquid BandageAleo Bme, Inc.K153571Cavilon Advanced High Endurance Skin Protectant3M HealthcareK160684Atteris No-Sting Skin ProtectantRochal Industries, LLCK120059LIQUID BANDAGEChesson Laboratory Associates, 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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