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FDA 510(k)

SOFT ULNAR DEVIATION SPLINTS

K-Number: K821635 · 1982-06-11

ApplicantFred Sammons, Inc.
Decision Date1982-06-11
Product CodeILH
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

SOFT ULNAR DEVIATION 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 1982-06-11 under 510(k) number K821635. 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 SOFT ULNAR DEVIATION SPLINTS?

SOFT ULNAR DEVIATION SPLINTS is a medical device that received FDA 510(k) clearance on 1982-06-11. The listed applicant is Fred Sammons, Inc.. The 510(k) number is K821635.

When did SOFT ULNAR DEVIATION SPLINTS receive FDA 510(k) clearance?

SOFT ULNAR DEVIATION SPLINTS received FDA 510(k) clearance on 1982-06-11, under 510(k) number K821635.

Who is the listed applicant for SOFT ULNAR DEVIATION 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 SOFT ULNAR DEVIATION SPLINTS?

The FDA product code for SOFT ULNAR DEVIATION SPLINTS is ILH.

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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 SLINGSK831548SPLINTSK831544DELUXE 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.K831548SPLINTSFred Sammons, Inc.K823644FINGER FLEXION SPLINTFred Sammons, Inc.K823647FINGER EXTENSION 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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