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FDA 510(k)

PDS ULTRACLEAN

K-Number: K934666 · 1994-04-15

ApplicantMedical Polymers, Inc.
Decision Date1994-04-15
Product CodeFLG
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

PDS ULTRACLEAN is the device name listed in this FDA 510(k) record. The listed applicant is Medical Polymers, Inc.. It received FDA 510(k) clearance on 1994-04-15 under 510(k) number K934666. The device is classified under product code FLG. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PDS ULTRACLEAN?

PDS ULTRACLEAN is a medical device that received FDA 510(k) clearance on 1994-04-15. The listed applicant is Medical Polymers, Inc.. The 510(k) number is K934666.

When did PDS ULTRACLEAN receive FDA 510(k) clearance?

PDS ULTRACLEAN received FDA 510(k) clearance on 1994-04-15, under 510(k) number K934666.

Who is the listed applicant for PDS ULTRACLEAN?

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

What is the FDA product code for PDS ULTRACLEAN?

The FDA product code for PDS ULTRACLEAN is FLG.

Related Clinical Trials

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.

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Other records listing Medical Polymers, 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.

K941365MPI DENTURE ADHESIVE FILM SEALSK921564POLYCLEAN

Related Devices (Code: FLG)

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.

K944950KLENZYMECalgon Corp.K944494ALSA-KLENZCalgon Vestal Div.K944033BILL EVANS-KLENZCalgon Vestal Div.K940263NPH-KLENZCalgon Corp.K941163MON-KLENZCalgon Vestal Div.K935063INSTRU KLENZCalgon Corp.

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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