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FDA 510(k)

AQUAPLAST

K-Number: K935067 · 1994-05-26

ApplicantWfr/Aquaplast Corp.
Decision Date1994-05-26
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

AQUAPLAST 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 1994-05-26 under 510(k) number K935067. 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 AQUAPLAST?

AQUAPLAST is a medical device that received FDA 510(k) clearance on 1994-05-26. The listed applicant is Wfr/Aquaplast Corp.. The 510(k) number is K935067.

When did AQUAPLAST receive FDA 510(k) clearance?

AQUAPLAST received FDA 510(k) clearance on 1994-05-26, under 510(k) number K935067.

Who is the listed applicant for AQUAPLAST?

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 AQUAPLAST?

The FDA product code for AQUAPLAST 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 RADIOLUCENTK021124ACCUFIX TILTING RADIOTRANSLUCENT HEADHOLDERK973370AQUAPLAST PALATAL STENTK943871AQUAPLAST TIE DOWN DRESSING

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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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