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FDA 510(k)

HAND SPLINTS & COMPONENTS

K-Number: K812349 · 1981-09-11

ApplicantFred Sammons, Inc.
Decision Date1981-09-11
Product CodeILH
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

HAND SPLINTS & COMPONENTS 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 1981-09-11 under 510(k) number K812349. 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 HAND SPLINTS & COMPONENTS?

HAND SPLINTS & COMPONENTS is a medical device that received FDA 510(k) clearance on 1981-09-11. The listed applicant is Fred Sammons, Inc.. The 510(k) number is K812349.

When did HAND SPLINTS & COMPONENTS receive FDA 510(k) clearance?

HAND SPLINTS & COMPONENTS received FDA 510(k) clearance on 1981-09-11, under 510(k) number K812349.

Who is the listed applicant for HAND SPLINTS & COMPONENTS?

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 HAND SPLINTS & COMPONENTS?

The FDA product code for HAND SPLINTS & COMPONENTS 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.

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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 SLINGSK831548SPLINTSK831550FINGER BONIOMETER BK7506K831544DELUXE TRACTION EXERCISE GLOVE BK5035

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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.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.

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