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FDA 510(k)

GLYCERIN & PARABEN FREE ASTROGLIDE

K-Number: K072647 · 2008-01-25

ApplicantBiofilm, Inc.
Decision Date2008-01-25
Product CodeNUC
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

GLYCERIN & PARABEN FREE ASTROGLIDE is the device name listed in this FDA 510(k) record. The listed applicant is Biofilm, Inc.. It received FDA 510(k) clearance on 2008-01-25 under 510(k) number K072647. 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 GLYCERIN & PARABEN FREE ASTROGLIDE?

GLYCERIN & PARABEN FREE ASTROGLIDE is a medical device that received FDA 510(k) clearance on 2008-01-25. The listed applicant is Biofilm, Inc.. The 510(k) number is K072647.

When did GLYCERIN & PARABEN FREE ASTROGLIDE receive FDA 510(k) clearance?

GLYCERIN & PARABEN FREE ASTROGLIDE received FDA 510(k) clearance on 2008-01-25, under 510(k) number K072647.

Who is the listed applicant for GLYCERIN & PARABEN FREE ASTROGLIDE?

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 GLYCERIN & PARABEN FREE ASTROGLIDE?

The FDA product code for GLYCERIN & PARABEN FREE ASTROGLIDE is NUC.

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.

Other records listing Biofilm, 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.

View all 14 devices →

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.

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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