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FDA 510(k)

Astroglide Glycerin & Paraben Free

K-Number: K220653 · 2022-05-06

ApplicantBiofilm, Inc.
Decision Date2022-05-06
Product CodeNUC
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Astroglide Glycerin & Paraben Free is the device name listed in this FDA 510(k) record. The listed applicant is Biofilm, Inc.. It received FDA 510(k) clearance on 2022-05-06 under 510(k) number K220653. The device is classified under product code NUC. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Astroglide Glycerin & Paraben Free?

Astroglide Glycerin & Paraben Free is a medical device that received FDA 510(k) clearance on 2022-05-06. The listed applicant is Biofilm, Inc.. The 510(k) number is K220653.

When did Astroglide Glycerin & Paraben Free receive FDA 510(k) clearance?

Astroglide Glycerin & Paraben Free received FDA 510(k) clearance on 2022-05-06, under 510(k) number K220653.

Who is the listed applicant for Astroglide Glycerin & Paraben Free?

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

What is the FDA product code for Astroglide Glycerin & Paraben Free?

The FDA product code for Astroglide Glycerin & Paraben Free is NUC.

Other records listing Biofilm, Inc. as applicant

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Related Devices (Code: NUC)

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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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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