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 Cranial Distraction System
510(k) Number K150771
Device Name RxG Distraction System
Applicant
KLS MARTIN L.P.
11201 SAINT JOHNS INDUSTRIAL PKWY. SOUTH
JACKSONVILLE,  FL  32246
Applicant Contact JENNIFER DAMATO
Correspondent
KLS MARTIN L.P.
11201 SAINT JOHNS INDUSTRIAL PKWY. SOUTH
JACKSONVILLE,  FL  32246
Correspondent Contact GARY MOORE
Regulation Number882.5330
Classification Product Code
PBJ  
Date Received03/24/2015
Decision Date 08/27/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-