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FDA 510(k)

PEDIATRIC MITTENS

K-Number: K963477 · 1996-11-12

ApplicantDeroyal Industries, Inc.
Decision Date1996-11-12
Product CodeFMQ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

PEDIATRIC MITTENS is the device name listed in this FDA 510(k) record. The listed applicant is Deroyal Industries, Inc.. It received FDA 510(k) clearance on 1996-11-12 under 510(k) number K963477. 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 PEDIATRIC MITTENS?

PEDIATRIC MITTENS is a medical device that received FDA 510(k) clearance on 1996-11-12. The listed applicant is Deroyal Industries, Inc.. The 510(k) number is K963477.

When did PEDIATRIC MITTENS receive FDA 510(k) clearance?

PEDIATRIC MITTENS received FDA 510(k) clearance on 1996-11-12, under 510(k) number K963477.

Who is the listed applicant for PEDIATRIC MITTENS?

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

What is the FDA product code for PEDIATRIC MITTENS?

The FDA product code for PEDIATRIC MITTENS is FMQ.

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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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