FDA 510(k) Application Details - K961884

Device Classification Name Tubes, Gastrointestinal (And Accessories)

  More FDA Info for this Device
510(K) Number K961884
Device Name Tubes, Gastrointestinal (And Accessories)
Applicant MARK-CLARK
3601 WEST 29TH ST.
TOPKA, KS 66614-2074 US
Other 510(k) Applications for this Company
Contact KEN WEDDLE
Other 510(k) Applications for this Contact
Regulation Number 876.5980

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

  More FDA Info for this Product Code
Date Received 05/15/1996
Decision Date 08/01/1996
Decision SESE - SUBST EQUIV
Classification Advisory Committee GU - Gastroenterology & Urology
Review Advisory Committee GU - Gastroenterology & Urology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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