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 K102173
Device Name MOLDEX-METRIC HEALTH CARE N95 PARTICULATE RESPIRATOR AND SURGICAL MASK, MODEL 1712
Applicant
Moldex/Metric, Inc.
10111 W. Jefferson Blvd.
Culver City,  CA  90232
Applicant Contact MARK MEINECKE
Correspondent
Intertek Testing Services
2307 E. Aurora Rd.
Unit B7
Twinsburg,  OH  44087
Correspondent Contact DANIEL W LEHTONEN
Regulation Number878.4040
Classification Product Code
MSH  
Date Received08/02/2010
Decision Date 09/13/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Summary Summary
Type Abbreviated
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-