FDA 510(k) Application Details - K974174

Device Classification Name Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece

  More FDA Info for this Device
510(K) Number K974174
Device Name Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
Applicant MEDNET LOCATOR, INC.
7000 SHADOW OAKS
MEMPHIS, TN 38125 US
Other 510(k) Applications for this Company
Contact JUDY CHANDLEER
Other 510(k) Applications for this Contact
Regulation Number 874.4250

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

  More FDA Info for this Product Code
Date Received 11/06/1997
Decision Date 03/10/1998
Decision SESE - SUBST EQUIV
Classification Advisory Committee EN - Ear, Nose, & Throat
Review Advisory Committee EN - Ear, Nose, & Throat
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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