FDA 510(k) Application Details - K984521

Device Classification Name Laryngostroboscope

  More FDA Info for this Device
510(K) Number K984521
Device Name Laryngostroboscope
Applicant RICHARD WOLF MEDICAL INSTRUMENTS CORP.
353 CORPORATE WOODS PKWY.
VERNON HILLS, IL 60061 US
Other 510(k) Applications for this Company
Contact ROBERT L CASARSA
Other 510(k) Applications for this Contact
Regulation Number 874.4750

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

  More FDA Info for this Product Code
Date Received 12/21/1998
Decision Date 03/17/1999
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