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)

PRE-FORMED SPLINT BLANKS

K-Number: K772416 · 1978-01-05

ApplicantFred Sammons, Inc.
Decision Date1978-01-05
Product CodeILH
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

PRE-FORMED SPLINT BLANKS 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 1978-01-05 under 510(k) number K772416. The device is classified under product code ILH. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PRE-FORMED SPLINT BLANKS?

PRE-FORMED SPLINT BLANKS is a medical device that received FDA 510(k) clearance on 1978-01-05. The listed applicant is Fred Sammons, Inc.. The 510(k) number is K772416.

When did PRE-FORMED SPLINT BLANKS receive FDA 510(k) clearance?

PRE-FORMED SPLINT BLANKS received FDA 510(k) clearance on 1978-01-05, under 510(k) number K772416.

Who is the listed applicant for PRE-FORMED SPLINT BLANKS?

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 PRE-FORMED SPLINT BLANKS?

The FDA product code for PRE-FORMED SPLINT BLANKS is ILH.

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: ILH)

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.

K832144SPLINT WOODVermont Wood Industries, Inc.K831548SPLINTSFred Sammons, Inc.K823647FINGER EXTENSION SPLINTFred Sammons, Inc.K823644FINGER FLEXION SPLINTFred Sammons, Inc.K823666UNIVERSAL WRIST SPLINT & FOREARM SPLINTWarm & Form, Orthopedic MaterialsK823601WRIST SUPPORTFred 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.

↑