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FDA 510(k)

ACCUFIX TILTING RADIOTRANSLUCENT HEADHOLDER

K-Number: K021124 · 2002-07-02

ApplicantWfr/Aquaplast Corp.
Decision Date2002-07-02
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ACCUFIX TILTING RADIOTRANSLUCENT HEADHOLDER is the device name listed in this FDA 510(k) record. The listed applicant is Wfr/Aquaplast Corp.. It received FDA 510(k) clearance on 2002-07-02 under 510(k) number K021124. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACCUFIX TILTING RADIOTRANSLUCENT HEADHOLDER?

ACCUFIX TILTING RADIOTRANSLUCENT HEADHOLDER is a medical device that received FDA 510(k) clearance on 2002-07-02. The listed applicant is Wfr/Aquaplast Corp.. The 510(k) number is K021124.

When did ACCUFIX TILTING RADIOTRANSLUCENT HEADHOLDER receive FDA 510(k) clearance?

ACCUFIX TILTING RADIOTRANSLUCENT HEADHOLDER received FDA 510(k) clearance on 2002-07-02, under 510(k) number K021124.

Who is the listed applicant for ACCUFIX TILTING RADIOTRANSLUCENT HEADHOLDER?

The FDA 510(k) record lists Wfr/Aquaplast Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ACCUFIX TILTING RADIOTRANSLUCENT HEADHOLDER?

The FDA product code for ACCUFIX TILTING RADIOTRANSLUCENT HEADHOLDER is IYE.

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Other records listing Wfr/Aquaplast 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.

K120916QFIX RADIOTHERAPY CHAIRK060671KVUE IGRT TREATMENT TABLE TOP, RT-4551KV, KVUE INSERTS AND ACCESSORIES, VARIOUSK032156ACCUFIX RADIOLUCENT PELVIS AND BELLY BOARDS, ACCUFIX CANTILEVER HEAD BOARD WITH SHOULDER DEPRESSION, ACCUFIX RADIOLUCENTK973370AQUAPLAST PALATAL STENTK943871AQUAPLAST TIE DOWN DRESSINGK942158AQUAPLAST NASAL SPLINTS, PRECUT SILVER SPLINT PATTERNS AND SPLINT KITS

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Related Devices (Code: IYE)

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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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