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)

P.S.M. JUSTA COVER

K-Number: K761072 · 1976-12-02

ApplicantThe Owenby Co.
Decision Date1976-12-02
Product CodeFXP
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

P.S.M. JUSTA COVER 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 1976-12-02 under 510(k) number K761072. The device is classified under product code FXP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the P.S.M. JUSTA COVER?

P.S.M. JUSTA COVER is a medical device that received FDA 510(k) clearance on 1976-12-02. The listed applicant is The Owenby Co.. The 510(k) number is K761072.

When did P.S.M. JUSTA COVER receive FDA 510(k) clearance?

P.S.M. JUSTA COVER received FDA 510(k) clearance on 1976-12-02, under 510(k) number K761072.

Who is the listed applicant for P.S.M. JUSTA COVER?

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 P.S.M. JUSTA COVER?

The FDA product code for P.S.M. JUSTA COVER is FXP.

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, PROTECTIVEK801627COVER, LIMBK801626ARM SLINGK801532STOCKINETTE, STERILE TWO PLY W/PULL TABSK801531ARM SLINGK790210STOCKINETTE, TUBULAR UNBLEACHED

View all 14 devices →

Related Devices (Code: FXP)

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.

K971076PRIMED SHOE COVERS, PRIMED HEAD COVERSPrimeline Medical Products, Inc.K971191FAR-EAST SHOE COVERSFar East Science & Technology Development Co., Ltd.K970815CONVERTORS IMPERVIOUS SHOE COVERSAllegiance Healthcare Corp.K961342SHOE COVER, NON-STERILECopioumed Intl., Inc.K955835FLUID BARRIER BOOT KNEE & ANKLE-HIGHInstrument Makar, Inc.K952897NIOMED SHOE COVERSAmerasia Corp.

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.

↑