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)

ORTHOLACE 4,5.6 EYELET

K-Number: K821859 · 1982-07-02

ApplicantFred Sammons, Inc.
Decision Date1982-07-02
Product CodeILD
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

ORTHOLACE 4,5.6 EYELET is the device name listed in this FDA 510(k) record. The listed applicant is Fred Sammons, Inc.. It received FDA 510(k) clearance on 1982-07-02 under 510(k) number K821859. The device is classified under product code ILD. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ORTHOLACE 4,5.6 EYELET?

ORTHOLACE 4,5.6 EYELET is a medical device that received FDA 510(k) clearance on 1982-07-02. The listed applicant is Fred Sammons, Inc.. The 510(k) number is K821859.

When did ORTHOLACE 4,5.6 EYELET receive FDA 510(k) clearance?

ORTHOLACE 4,5.6 EYELET received FDA 510(k) clearance on 1982-07-02, under 510(k) number K821859.

Who is the listed applicant for ORTHOLACE 4,5.6 EYELET?

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

What is the FDA product code for ORTHOLACE 4,5.6 EYELET?

The FDA product code for ORTHOLACE 4,5.6 EYELET is ILD.

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 Fred Sammons, 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.

K880644ULTRA-PAN FOR ORTHOTIC PLASTICS (7262)K880647ADULT PERCEPTUAL MOTOR PUZZLES (5331-01)K831549ARM SLINGSK831548SPLINTSK831550FINGER BONIOMETER BK7506K831544DELUXE TRACTION EXERCISE GLOVE BK5035

View all 278 devices →

Related Devices (Code: ILD)

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.

K831539ECONOMY PLASTIC SOCK-BK2084-AIDFred Sammons, Inc.K823603FORMED PLASTIC PANTY HOSE AIDFred Sammons, Inc.K823604ROD W/HOOK TO PULL CLOTHES ONFred Sammons, Inc.K823628LEATHER & VELCRO SHOE FASTENERFred Sammons, Inc.K823627LEATHER I VELCRO SHOE FASTENER REPAIRFred Sammons, Inc.K823602REGULAR SHOE HORN W/CYLINDRICAL HANDLEFred Sammons, 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.

↑