Pharmapac Lubricating Jelly

FDA 510(k) K070623 · Pharmapac, LLC

Substantially Equivalent

510(k) numberK070623

Submission

Device name
Pharmapac Lubricating Jelly
Applicant
Pharmapac, LLC
Dekalb, MS, US
Received
March 6, 2007
Decision date
August 31, 2007
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA
Third-party review
Yes

Official FDA 510(k) record

Device classification

Product code
NUC – Lubricant, Personal
Device class
Class II (moderate risk)
Regulation
21 CFR 884.5300
Specialty
Obstetrics/Gynecology

This device is a personal lubricant, for penile and/or vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity, and supplement the body's natural lubrication. This product may or may not be compatible with natural rubber latex, polyisoprene, and/or polyurethane condoms.

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More from Hudi Pharma Srl

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Questions and answers

When was Pharmapac Lubricating Jelly cleared by the FDA?

Pharmapac Lubricating Jelly (K070623) received a 510(k) decision of Substantially Equivalent on August 31, 2007, 178 days after the submission was received.

What is the product code of K070623?

The FDA product code is NUC – Lubricant, Personal, a Class II (moderate risk) device regulated under 21 CFR 884.5300.