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FDA 510(k)

EXAM ROOM ASTROGLIDE (PROFESSIONAL MARKET), TARGET LUBRICATING JELLY (OTC CONSUMER MARKET)

K-Number: K003867 · 2001-03-09

ApplicantBiofilm, Inc.
Decision Date2001-03-09
Product CodeNUC
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

EXAM ROOM ASTROGLIDE (PROFESSIONAL MARKET), TARGET LUBRICATING JELLY (OTC CONSUMER MARKET) is the device name listed in this FDA 510(k) record. The listed applicant is Biofilm, Inc.. It received FDA 510(k) clearance on 2001-03-09 under 510(k) number K003867. 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 EXAM ROOM ASTROGLIDE (PROFESSIONAL MARKET), TARGET LUBRICATING JELLY (OTC CONSUMER MARKET)?

EXAM ROOM ASTROGLIDE (PROFESSIONAL MARKET), TARGET LUBRICATING JELLY (OTC CONSUMER MARKET) is a medical device that received FDA 510(k) clearance on 2001-03-09. The listed applicant is Biofilm, Inc.. The 510(k) number is K003867.

When did EXAM ROOM ASTROGLIDE (PROFESSIONAL MARKET), TARGET LUBRICATING JELLY (OTC CONSUMER MARKET) receive FDA 510(k) clearance?

EXAM ROOM ASTROGLIDE (PROFESSIONAL MARKET), TARGET LUBRICATING JELLY (OTC CONSUMER MARKET) received FDA 510(k) clearance on 2001-03-09, under 510(k) number K003867.

Who is the listed applicant for EXAM ROOM ASTROGLIDE (PROFESSIONAL MARKET), TARGET LUBRICATING JELLY (OTC CONSUMER MARKET)?

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 EXAM ROOM ASTROGLIDE (PROFESSIONAL MARKET), TARGET LUBRICATING JELLY (OTC CONSUMER MARKET)?

The FDA product code for EXAM ROOM ASTROGLIDE (PROFESSIONAL MARKET), TARGET LUBRICATING JELLY (OTC CONSUMER MARKET) is NUC.

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Related Devices (Code: NUC)

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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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