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FDA 510(k)

SPLINTS

K-Number: K831548 · 1983-06-27

ApplicantFred Sammons, Inc.
Decision Date1983-06-27
Product CodeILH
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

SPLINTS 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 1983-06-27 under 510(k) number K831548. 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 SPLINTS?

SPLINTS is a medical device that received FDA 510(k) clearance on 1983-06-27. The listed applicant is Fred Sammons, Inc.. The 510(k) number is K831548.

When did SPLINTS receive FDA 510(k) clearance?

SPLINTS received FDA 510(k) clearance on 1983-06-27, under 510(k) number K831548.

Who is the listed applicant for SPLINTS?

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 SPLINTS?

The FDA product code for SPLINTS is ILH.

Related Clinical Trials

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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 SLINGSK831550FINGER BONIOMETER BK7506K831544DELUXE TRACTION EXERCISE GLOVE BK5035K831542ADJUSTABLE POLYCENTRIC ELBOW HINGE

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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.K823647FINGER EXTENSION SPLINTFred Sammons, Inc.K823644FINGER FLEXION SPLINTFred Sammons, Inc.K823666UNIVERSAL WRIST SPLINT & FOREARM SPLINTWarm & Form, Orthopedic MaterialsK823601WRIST SUPPORTFred Sammons, Inc.K823393STAX FINGER SPLINTSOrthopedic Systems, 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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