Comfort Personal Lubricant

FDA 510(k) K915574 · Hyman, Phelps & McNamara, P.C.

Substantially Equivalent

510(k) numberK915574

Submission

Device name
Comfort Personal Lubricant
Applicant
Hyman, Phelps & McNamara, P.C.
Woodland Hills, CA, US
Received
December 12, 1991
Decision date
February 19, 1993
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
KMJ – Lubricant, Patient
Device class
Class I (low risk)
Regulation
21 CFR 880.6375
Specialty
General Hospital

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Questions and answers

When was Comfort Personal Lubricant cleared by the FDA?

Comfort Personal Lubricant (K915574) received a 510(k) decision of Substantially Equivalent on February 19, 1993, 435 days after the submission was received.

What is the product code of K915574?

The FDA product code is KMJ – Lubricant, Patient, a Class I (low risk) device regulated under 21 CFR 880.6375.