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FDA 510(k)

GAUZE BANDAGE

K-Number: K831284 · 1983-08-12

ApplicantPac-Kit Safety Equipment Co.
Decision Date1983-08-12
Product CodeNAB
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

GAUZE BANDAGE is the device name listed in this FDA 510(k) record. The listed applicant is Pac-Kit Safety Equipment Co.. It received FDA 510(k) clearance on 1983-08-12 under 510(k) number K831284. The device is classified under product code NAB. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GAUZE BANDAGE?

GAUZE BANDAGE is a medical device that received FDA 510(k) clearance on 1983-08-12. The listed applicant is Pac-Kit Safety Equipment Co.. The 510(k) number is K831284.

When did GAUZE BANDAGE receive FDA 510(k) clearance?

GAUZE BANDAGE received FDA 510(k) clearance on 1983-08-12, under 510(k) number K831284.

Who is the listed applicant for GAUZE BANDAGE?

The FDA 510(k) record lists Pac-Kit Safety Equipment Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GAUZE BANDAGE?

The FDA product code for GAUZE BANDAGE is NAB.

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 Pac-Kit Safety Equipment Co. 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.

K831282BANDAGE COMPRESSK831281GAUZE COMPRESSK831283TRIANGLE BANDAGE STERILE

Related Devices (Code: NAB)

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.

K946015IVALON EXTERNAL SPONGEIvalonK940755ISOLYER (4X4, 8PLY)Isolyer Co.K931610OMNISORB II, NONWOVEN SPONGE, STERILE AND NONOmni Mfg., Inc.K925590MULTI-TRAUMA DRESSINGGam Industries, Inc.K926072K-BAND AND K-CREPEParema , Ltd.K915591STERILE GAUZE PADSEagle Medical, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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