SHEFFIELD PHARMACEUTICALS (STERILE) LUBRIGEL


Device Classification Name

lubricant, vaginal, patient

510(k) Number K073684
Device Name SHEFFIELD PHARMACEUTICALS (STERILE) LUBRIGEL
Applicant
SHEFFIELD INDUSTRIES, DIV. OF FARIA LTD.
170 broad st.
new london, 
CT 
06320

Applicant Contact kathleen hacku
Correspondent
SHEFFIELD INDUSTRIES, DIV. OF FARIA LTD.
170 broad st.
new london, 
CT 
06320

Correspodent Contact kathleen hacku
Regulation Number 880.6375
Classification Product Code
MMS  
Date Received 12/28/2007
Decision Date 05/22/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General Hospital

510k Review Panel

Obstetrics/Gynecology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No