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 orthosis, cranial
510(k) Number K193383
Device Name SnugKap
Applicant
HeadStart, Ltd.
1550 E. Higgins Road, Suite 123
Elk Grove Village,  IL  60007
Applicant Contact James McCartney
Correspondent
MCRA, LLC
1050 K Street NW, Suite 1000
Washington,  DC  20001
Correspondent Contact Dave McGurl
Regulation Number882.5970
Classification Product Code
MVA  
Date Received12/05/2019
Decision Date 06/07/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-