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FDA 510(k)

CHECKMATE ANKLE RESTRAINT SYSTEM

K-Number: K962963 · 1996-10-24

ApplicantHollister, Inc.
Decision Date1996-10-24
Product CodeFMQ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

CHECKMATE ANKLE RESTRAINT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Hollister, Inc.. It received FDA 510(k) clearance on 1996-10-24 under 510(k) number K962963. The device is classified under product code FMQ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CHECKMATE ANKLE RESTRAINT SYSTEM?

CHECKMATE ANKLE RESTRAINT SYSTEM is a medical device that received FDA 510(k) clearance on 1996-10-24. The listed applicant is Hollister, Inc.. The 510(k) number is K962963.

When did CHECKMATE ANKLE RESTRAINT SYSTEM receive FDA 510(k) clearance?

CHECKMATE ANKLE RESTRAINT SYSTEM received FDA 510(k) clearance on 1996-10-24, under 510(k) number K962963.

Who is the listed applicant for CHECKMATE ANKLE RESTRAINT SYSTEM?

The FDA 510(k) record lists Hollister, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CHECKMATE ANKLE RESTRAINT SYSTEM?

The FDA product code for CHECKMATE ANKLE RESTRAINT SYSTEM is FMQ.

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Other records listing Hollister, Inc. as applicant

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K123804INSTAFLO BOWEL CATHETER SYSTEM KITK100273INSTAFLO BOWEL CATHETER SYSTEM KITK090960VAPRO INTERMITTENT CATHETER, MODEL 72062, 72082,72102, 72122, 72142, 72064, 72084, 72104, 72124,72144, 72164, 72184,K083153ACTIFLO INDWELLING BOWEL CATHETER SYSTEM KIT, MODELS: 32004, 32005, 32006, 32007K050483EVADRI BLADDER CONTROL SYSTEMSK040779RESTORE WOUND CLEANSER

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Related Devices (Code: FMQ)

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.

K110377PROTECTIVE RESTRAINTMedi-Tech Intl. Corp.K081264STATSTRAP NEONATAL INCUBATOR SAFETY STRAP, MODELS SS-001, SS-002Children'S Health First, Inc.K080448CENTURION PROTECTIVE RESTRAINT, SCR SERIESTri-State Hospital Supply Corp.K013239COMFORTCARE COMPRESSION SUPPORT WITH MAGNETS COMFORTCARE MAGNETIC INSOLESMed Gen, Inc.K010818INFANT LIMB HOLDER, MODELS 306080 & 306081Skil-Care Corp.K010644CINCH-TYPE DISPOSABLE LIMB HOLDERS, MODEL 912025Skil-Care Corp.

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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