Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name Respirator, Surgical
510(k) Number K070139
Device Name WILLSON ONE-FIT HEALTHCARE PARTICLE RESPIRATOR AND SURGICAL MASK, HC-NB095
Applicant
Survivair, Inc.
1025 W. Everett Rd.
Lake Forest,  IL  60045
Applicant Contact RICHARD O WOOD
Correspondent
Survivair, Inc.
1025 W. Everett Rd.
Lake Forest,  IL  60045
Correspondent Contact RICHARD O WOOD
Regulation Number878.4040
Classification Product Code
MSH  
Date Received01/16/2007
Decision Date 03/02/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-