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FDA 510(k)

PEDIATRIC POSITION HOLDER

K-Number: K810609 · 1981-03-20

ApplicantKaye Products, Inc.
Decision Date1981-03-20
Product CodeFRP
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

PEDIATRIC POSITION HOLDER is the device name listed in this FDA 510(k) record. The listed applicant is Kaye Products, Inc.. It received FDA 510(k) clearance on 1981-03-20 under 510(k) number K810609. The device is classified under product code FRP. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PEDIATRIC POSITION HOLDER?

PEDIATRIC POSITION HOLDER is a medical device that received FDA 510(k) clearance on 1981-03-20. The listed applicant is Kaye Products, Inc.. The 510(k) number is K810609.

When did PEDIATRIC POSITION HOLDER receive FDA 510(k) clearance?

PEDIATRIC POSITION HOLDER received FDA 510(k) clearance on 1981-03-20, under 510(k) number K810609.

Who is the listed applicant for PEDIATRIC POSITION HOLDER?

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

What is the FDA product code for PEDIATRIC POSITION HOLDER?

The FDA product code for PEDIATRIC POSITION HOLDER is FRP.

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Other records listing Kaye Products, 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.

K924848KAYE SCOOT-ABOUT, MODEL SB1K923095KAYE MODEL KIAO PELVIC/THIGH STABILIZERK922061CHAIR, ADJUSTABLE, MECHANICALK885330WHEELCHAIR, MECHANICALK833869CHILD'S WALKERK830560EXERCISER, PASSIVE, NON MEASURING

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Related Devices (Code: FRP)

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.

K082367INFANT SLEEP BEANIELife Innovations, LLCK090284RES-Q INFANT WEDGE AND SLINGCr Enterprises, LLCK062143KOZY COMFORT INFANT POSITIONERAlfred E Mann Inst. For Biomedical EngineeringK060986HEAD BEDSteven H. Warnock, M.D.K051300ROBIN HOOD VESTKamber CorporationK041996NIGHTFORMPlastic Surgery Solutions, LLC

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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