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FDA 510(k)

ADJUSTABLE POLYCENTRIC ELBOW HINGE

K-Number: K831542 · 1983-06-24

ApplicantFred Sammons, Inc.
Decision Date1983-06-24
Product CodeIQI
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

ADJUSTABLE POLYCENTRIC ELBOW HINGE 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 1983-06-24 under 510(k) number K831542. The device is classified under product code IQI. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ADJUSTABLE POLYCENTRIC ELBOW HINGE?

ADJUSTABLE POLYCENTRIC ELBOW HINGE is a medical device that received FDA 510(k) clearance on 1983-06-24. The listed applicant is Fred Sammons, Inc.. The 510(k) number is K831542.

When did ADJUSTABLE POLYCENTRIC ELBOW HINGE receive FDA 510(k) clearance?

ADJUSTABLE POLYCENTRIC ELBOW HINGE received FDA 510(k) clearance on 1983-06-24, under 510(k) number K831542.

Who is the listed applicant for ADJUSTABLE POLYCENTRIC ELBOW HINGE?

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 ADJUSTABLE POLYCENTRIC ELBOW HINGE?

The FDA product code for ADJUSTABLE POLYCENTRIC ELBOW HINGE is IQI.

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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: IQI)

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.

K052771SENSOR WALKOtto Bock Healthcare LPK031576SPARTAN ORTHOPAEDIC WRIST BRACE, MODEL SCT-1Surgitech, Inc.K926391ACCUFLEX DYNAMIC ELBOW ORTHOSISRegulatory & Marketing Services, Inc.K910974MCCONNELL SHOULDER BRACEMcconnell OrthopedicK874502GAIT-AID ORTHOPEDIC INSOLEGait-Aid, Inc.K831615DROP FOOT BRACEEdward Dilauro, Jr.

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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