LUBRIGEL PERSONAL LUBRICANT


the company

Device Classification Name

lubricant, personal

510(k) Number K001077
Device Name LUBRIGEL PERSONAL LUBRICANT
Original Applicant
SHEFFIELD LABORATORIES, DIV. OF FARIA LIMITED, LLC
170 broad st.
new london, 
CT 
06320

Original Contact kathleen hacku
Regulation Number 884.5300
Classification Product Code
NUC  
Date Received 04/04/2000
Decision Date 08/02/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Obstetrics/Gynecology

510k Review Panel

Obstetrics/Gynecology

Type Traditional
Reviewed by Third Party No

Combination Product

No