FDA 510(k) Application Details - K070782

Device Classification Name Respirator,Surgical

  More FDA Info for this Device
510(K) Number K070782
Device Name Respirator,Surgical
Applicant SURVIVAIR RESPIRATORS, LLC
1025 W. EVERETT RD.
LAKE FOREST, IL 60045 US
Other 510(k) Applications for this Company
Contact RICHARD O WOOD
Other 510(k) Applications for this Contact
Regulation Number 878.4040

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

  More FDA Info for this Product Code
Date Received 03/21/2007
Decision Date 04/11/2007
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Summary
Type Abbreviated
Reviewed By Third Party N
Expedited Review



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