FDA 510(k) Application Details - K972855

Device Classification Name Nasopharyngoscope (Flexible Or Rigid)

  More FDA Info for this Device
510(K) Number K972855
Device Name Nasopharyngoscope (Flexible Or Rigid)
Applicant KARL STORZ ENDOSCOPY-AMERICA, INC.
600 CORPORATE POINTE
CULVER CITY, CA 90230-7600 US
Other 510(k) Applications for this Company
Contact MARIKA ANDERSON
Other 510(k) Applications for this Contact
Regulation Number 874.4760

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

  More FDA Info for this Product Code
Date Received 08/01/1997
Decision Date 09/08/1997
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