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 Laser, Comb, Hair
510(k) Number K091496
FOIA Releasable 510(k) K091496
Device Name MEP-90 HAIR GROWTH STIMULATION SYSTEM
Applicant
MIDWEST R.F. LLC.
1050 WALNUT RIDGE DRIVE
HARTLAND,  WI  53029
Applicant Contact HELMUT KEIDL
Correspondent
MIDWEST R.F. LLC.
1050 WALNUT RIDGE DRIVE
HARTLAND,  WI  53029
Correspondent Contact HELMUT KEIDL
Regulation Number890.5500
Classification Product Code
OAP  
Date Received05/20/2009
Decision Date 02/23/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-