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FDA 510(k)

DEROYAL INDUSTRIES INFANT HEEL WARMER

K-Number: K954716 · 1996-01-11

ApplicantDebusk Knitting Mills, Div. Deroyal Industries
Decision Date1996-01-11
Product CodeMPO
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

DEROYAL INDUSTRIES INFANT HEEL WARMER is the device name listed in this FDA 510(k) record. The listed applicant is Debusk Knitting Mills, Div. Deroyal Industries. It received FDA 510(k) clearance on 1996-01-11 under 510(k) number K954716. The device is classified under product code MPO. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DEROYAL INDUSTRIES INFANT HEEL WARMER?

DEROYAL INDUSTRIES INFANT HEEL WARMER is a medical device that received FDA 510(k) clearance on 1996-01-11. The listed applicant is Debusk Knitting Mills, Div. Deroyal Industries. The 510(k) number is K954716.

When did DEROYAL INDUSTRIES INFANT HEEL WARMER receive FDA 510(k) clearance?

DEROYAL INDUSTRIES INFANT HEEL WARMER received FDA 510(k) clearance on 1996-01-11, under 510(k) number K954716.

Who is the listed applicant for DEROYAL INDUSTRIES INFANT HEEL WARMER?

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

What is the FDA product code for DEROYAL INDUSTRIES INFANT HEEL WARMER?

The FDA product code for DEROYAL INDUSTRIES INFANT HEEL WARMER is MPO.

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Other records listing Debusk Knitting Mills, Div. Deroyal Industries 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.

K961097ELECTROSURGICAL CUTTING & COAGULATION DEVICE & ACCESSORIESK961085DEROYAL WOUND CARE MULTIDEX PLUS GEL WOUND DRESSINGK961087DEROYAL SURGICAL (SURGIMATE) PENCIL ADAPTERS

Related Devices (Code: MPO)

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.

K221154Infant Heel WarmerTM; Heel Snuggler®International BiomedicalK151845Infant Heel Warmer (Model 24401) and WarmGel Infant Heel Warmer (Model 20418)CooperSurgical, Inc.K103549DENOVO TEDDY GEL INFANT HEEL WARMERDenovo Products, LLCK053254INFANT HEEL WARMER BY INTCOShanghai Intco Medical Supply Co., Ltd.K040856RAPID AID INSTANT DISPOSABLE INFANT HEEL WARMERRapid Aid , Ltd.K040044HEEL SNUGGLER, MODEL 99047Respironics, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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