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FDA 510(k)

CINCH-TYPE DISPOSABLE LIMB HOLDERS, MODEL 912025

K-Number: K010644 · 2001-05-18

ApplicantSkil-Care Corp.
Decision Date2001-05-18
Product CodeFMQ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

CINCH-TYPE DISPOSABLE LIMB HOLDERS, MODEL 912025 is the device name listed in this FDA 510(k) record. The listed applicant is Skil-Care Corp.. It received FDA 510(k) clearance on 2001-05-18 under 510(k) number K010644. 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 CINCH-TYPE DISPOSABLE LIMB HOLDERS, MODEL 912025?

CINCH-TYPE DISPOSABLE LIMB HOLDERS, MODEL 912025 is a medical device that received FDA 510(k) clearance on 2001-05-18. The listed applicant is Skil-Care Corp.. The 510(k) number is K010644.

When did CINCH-TYPE DISPOSABLE LIMB HOLDERS, MODEL 912025 receive FDA 510(k) clearance?

CINCH-TYPE DISPOSABLE LIMB HOLDERS, MODEL 912025 received FDA 510(k) clearance on 2001-05-18, under 510(k) number K010644.

Who is the listed applicant for CINCH-TYPE DISPOSABLE LIMB HOLDERS, MODEL 912025?

The FDA 510(k) record lists Skil-Care Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CINCH-TYPE DISPOSABLE LIMB HOLDERS, MODEL 912025?

The FDA product code for CINCH-TYPE DISPOSABLE LIMB HOLDERS, MODEL 912025 is FMQ.

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Other records listing Skil-Care Corp. 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.

K010818INFANT LIMB HOLDER, MODELS 306080 & 306081K963458PADDED MITTS/PADDED-PLUS MITTS/FINGER SEPARATOR PADDED MITTS/RIGID PALM PADDED MITTSK963459SUPPORT VESTK963461SAFETY PONCHO/SHOULDER STRAP PONCHOK963460ROLL BELTK963457SLEEPER JACKET/HOUDINI SAFETY SLEEPER

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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.K991591BIOTHANE PATIENT RESTRAINTBioplastics

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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