VARIOUS ANSELL TRADENAMES OR PRIVATE LABEL


Device Classification Name

condom

510(k) Number K992081
Device Name VARIOUS ANSELL TRADENAMES OR PRIVATE LABEL
Applicant
SURETEX PROPHYLACTICS (INDIA) LTD.
1500 industrial rd.
p.o. box 1252
dothan, 
AL 
36302

Applicant Contact lon d mcilvain
Correspondent
SURETEX PROPHYLACTICS (INDIA) LTD.
1500 industrial rd.
p.o. box 1252
dothan, 
AL 
36302

Correspodent Contact lon d mcilvain
Regulation Number 884.5300
Classification Product Code
HIS  
Date Received 06/21/1999
Decision Date 08/19/1999
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Obstetrics/Gynecology

510k Review Panel

Obstetrics/Gynecology

summary

summary

Type Abbreviated
Reviewed by Third Party No

Combination Product

No