FDA 510(k) Application Details - K993583

Device Classification Name Replacement, Ossicular Prosthesis, Total

  More FDA Info for this Device
510(K) Number K993583
Device Name Replacement, Ossicular Prosthesis, Total
Applicant STRYKER CORP.
4100 EAST MILHAM AVE.
KALAMAZOO, MI 49001-6197 US
Other 510(k) Applications for this Company
Contact NICOLE PETTY
Other 510(k) Applications for this Contact
Regulation Number 874.3495

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

  More FDA Info for this Product Code
Date Received 10/22/1999
Decision Date 11/10/1999
Decision SESE - SUBST EQUIV
Classification Advisory Committee EN - Ear, Nose, & Throat
Review Advisory Committee EN - Ear, Nose, & Throat
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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