FDA 510(k)

MucoPEG

K-Number: K190144 · 2019-11-05

Decision Date2019-11-05

Product CodeLFD

DecisionSubstantially Equivalent

Device Summary

MucoPEG is the device name listed in this FDA 510(k) record. The listed applicant is Sunbio, Inc.. It received FDA 510(k) clearance on 2019-11-05 under 510(k) number K190144. The device is classified under product code LFD. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MucoPEG?

MucoPEG is a medical device that received FDA 510(k) clearance on 2019-11-05. The listed applicant is Sunbio, Inc.. The 510(k) number is K190144.

When did MucoPEG receive FDA 510(k) clearance?

MucoPEG received FDA 510(k) clearance on 2019-11-05, under 510(k) number K190144.

Who is the listed applicant for MucoPEG?

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

What is the FDA product code for MucoPEG?

The FDA product code for MucoPEG is LFD.

Related Devices (Code: LFD)

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.

K253778Allday Moisturizing RinseElevate Oral Care K250390CloSYS® Dry Mouth Sensitive Mouth RinseRowpar Pharmaceuticals, Inc.K240508Salivea Dry Mouth Moisturizing Gel (Dry Mouth Moisturizing Gel)Laclede, Inc.K234015Caphosol® Artifical Saliva (32 doses sachet box)Eusa Pharma (Uk) Limited K231205GuruNanda Dry Mouth Oral Rinse and GuruNanda Dry Mouth Oral SprayGurunanda, LLC K202689Dentilube SprayOxy2plus, LLC

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.