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FDA 510(k)

ONE HANDED SHOE FASTENER

K-Number: K813634 · 1982-01-19

ApplicantFred Sammons, Inc.
Decision Date1982-01-19
Product CodeILD
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

ONE HANDED SHOE FASTENER 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 1982-01-19 under 510(k) number K813634. The device is classified under product code ILD. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ONE HANDED SHOE FASTENER?

ONE HANDED SHOE FASTENER is a medical device that received FDA 510(k) clearance on 1982-01-19. The listed applicant is Fred Sammons, Inc.. The 510(k) number is K813634.

When did ONE HANDED SHOE FASTENER receive FDA 510(k) clearance?

ONE HANDED SHOE FASTENER received FDA 510(k) clearance on 1982-01-19, under 510(k) number K813634.

Who is the listed applicant for ONE HANDED SHOE FASTENER?

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 ONE HANDED SHOE FASTENER?

The FDA product code for ONE HANDED SHOE FASTENER is ILD.

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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: ILD)

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.

K831539ECONOMY PLASTIC SOCK-BK2084-AIDFred Sammons, Inc.K823603FORMED PLASTIC PANTY HOSE AIDFred Sammons, Inc.K823604ROD W/HOOK TO PULL CLOTHES ONFred Sammons, Inc.K823628LEATHER & VELCRO SHOE FASTENERFred Sammons, Inc.K823627LEATHER I VELCRO SHOE FASTENER REPAIRFred Sammons, Inc.K823602REGULAR SHOE HORN W/CYLINDRICAL HANDLEFred 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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