FDA 510(k) Application Details - K972151

Device Classification Name Splint, Intranasal Septal

  More FDA Info for this Device
510(K) Number K972151
Device Name Splint, Intranasal Septal
Applicant BOSTON MEDICAL PRODUCTS, INC.
117 FLANDERS RD.
WESTBOROUGH, MA 01581 US
Other 510(k) Applications for this Company
Contact STUART K MONTGOMERY
Other 510(k) Applications for this Contact
Regulation Number 874.4780

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

  More FDA Info for this Product Code
Date Received 06/09/1997
Decision Date 07/07/1997
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