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FDA 510(k)

ADI STERILE GAUZE SPONGES

K-Number: K953501 · 1995-08-28

ApplicantAsia Dynamics, Inc.
Decision Date1995-08-28
Product CodeEFQ
DecisionSubstantially Equivalent

Device Summary

ADI STERILE GAUZE SPONGES 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 1995-08-28 under 510(k) number K953501. The device is classified under product code EFQ. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ADI STERILE GAUZE SPONGES?

ADI STERILE GAUZE SPONGES is a medical device that received FDA 510(k) clearance on 1995-08-28. The listed applicant is Asia Dynamics, Inc.. The 510(k) number is K953501.

When did ADI STERILE GAUZE SPONGES receive FDA 510(k) clearance?

ADI STERILE GAUZE SPONGES received FDA 510(k) clearance on 1995-08-28, under 510(k) number K953501.

Who is the listed applicant for ADI STERILE GAUZE SPONGES?

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 ADI STERILE GAUZE SPONGES?

The FDA product code for ADI STERILE GAUZE SPONGES is EFQ.

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 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.

K953500HEMO-BARRIERK952924ADI CATHETER WITH VALVEK891160MIC NON-STERILE LATEX GLOVES

Related Devices (Code: EFQ)

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.

K991757NON-ABSORBABLE GAUZE FOR EXTERNAL USE, STERILE AND NON STERILEFurlong IndustriesK991215SYMTEX GAUZE PADS (1'S) AND SYMTEX GAUZE SPONGES STERILE 2'S AND STERILE 10'SSymtex Healthcare Corp.K990974VITOP DRESSINGWonder & Bioenergy Hi-Tech America, Inc.K990584GAUZE SPONGES: LAPAROTOMY SPONGE, X-RAY DETECTABLEBroadline Medical IndustriesK984187CROSSTEX NON-WOVEN SPONGESCrosstex Intl.K983016GAUZE, SPONGES, CAT # 11-003Vitalcare Group, 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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