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FDA 510(k)

INFANT LIMB HOLDER, MODELS 306080 & 306081

K-Number: K010818 · 2001-05-24

ApplicantSkil-Care Corp.
Decision Date2001-05-24
Product CodeFMQ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

INFANT LIMB HOLDER, MODELS 306080 & 306081 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 2001-05-24 under 510(k) number K010818. 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 INFANT LIMB HOLDER, MODELS 306080 & 306081?

INFANT LIMB HOLDER, MODELS 306080 & 306081 is a medical device that received FDA 510(k) clearance on 2001-05-24. The listed applicant is Skil-Care Corp.. The 510(k) number is K010818.

When did INFANT LIMB HOLDER, MODELS 306080 & 306081 receive FDA 510(k) clearance?

INFANT LIMB HOLDER, MODELS 306080 & 306081 received FDA 510(k) clearance on 2001-05-24, under 510(k) number K010818.

Who is the listed applicant for INFANT LIMB HOLDER, MODELS 306080 & 306081?

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 INFANT LIMB HOLDER, MODELS 306080 & 306081?

The FDA product code for INFANT LIMB HOLDER, MODELS 306080 & 306081 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.

K010644CINCH-TYPE DISPOSABLE LIMB HOLDERS, MODEL 912025K963458PADDED 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.K010644CINCH-TYPE DISPOSABLE LIMB HOLDERS, MODEL 912025Skil-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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