Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

NON-STERILE FOLDED GAUZE

K-Number: K780764 · 1978-06-06

ApplicantThe Owenby Co.
Decision Date1978-06-06
Product CodeNAB
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

NON-STERILE FOLDED GAUZE is the device name listed in this FDA 510(k) record. The listed applicant is The Owenby Co.. It received FDA 510(k) clearance on 1978-06-06 under 510(k) number K780764. 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 NON-STERILE FOLDED GAUZE?

NON-STERILE FOLDED GAUZE is a medical device that received FDA 510(k) clearance on 1978-06-06. The listed applicant is The Owenby Co.. The 510(k) number is K780764.

When did NON-STERILE FOLDED GAUZE receive FDA 510(k) clearance?

NON-STERILE FOLDED GAUZE received FDA 510(k) clearance on 1978-06-06, under 510(k) number K780764.

Who is the listed applicant for NON-STERILE FOLDED GAUZE?

The FDA 510(k) record lists The Owenby Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NON-STERILE FOLDED GAUZE?

The FDA product code for NON-STERILE FOLDED GAUZE 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 The Owenby 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.

K801628RESTRAINT, PROTECTIVEK801532STOCKINETTE, STERILE TWO PLY W/PULL TABSK801626ARM SLINGK801627COVER, LIMBK801531ARM SLINGK790210STOCKINETTE, TUBULAR UNBLEACHED

View all 14 devices →

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.

↑