FDA 510(k) Application Details - K993781

Device Classification Name Condom

  More FDA Info for this Device
510(K) Number K993781
Device Name Condom
Applicant P.T. VONIX LATEXINDO CONDOM (RUBBER) MFG.
7 RIVERVIEW RD.
FRAMINGHAM, MA 01701 US
Other 510(k) Applications for this Company
Contact VIJAY MAHAL
Other 510(k) Applications for this Contact
Regulation Number 884.5300

  More FDA Info for this Regulation Number
Classification Product Code HIS
Other 510(k) Applications for this Device

  More FDA Info for this Product Code
Date Received 11/08/1999
Decision Date 02/02/2000
Decision SESE - SUBST EQUIV
Classification Advisory Committee OB - Obstetrics/Gynecology
Review Advisory Committee OB - Obstetrics/Gynecology
Statement / Summary / Purged Status Summary
Type Abbreviated
Reviewed By Third Party N
Expedited Review



Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact