FDA 510(k) Application Details - K951431

Device Classification Name Lubricant, Patient

  More FDA Info for this Device
510(K) Number K951431
Device Name Lubricant, Patient
Applicant DEPUY HEALTHCARE
93 BIRCH HILL RD.
STOW, MA US
Other 510(k) Applications for this Company
Contact JAMES M PARKER
Other 510(k) Applications for this Contact
Regulation Number 880.6375

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

  More FDA Info for this Product Code
Date Received 03/27/1995
Decision Date 07/21/1995
Decision SE - Substantially Equivalent
Classification Advisory Committee OB - Obstetrics/Gynecology
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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