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 Sleeve, Limb, Compressible
510(k) Number K143317
Device Name Currie Medical ALP Pediatric Calf Compression Sleeves (all sizes)
Applicant
Currie Medical Specialties, Inc.
8758 Hellman Ave.
Rancho Cucamonga,  CA  91730
Applicant Contact Owen J. Bry
Correspondent
Currie Medical Specialties, Inc.
8758 Hellman Ave.
Rancho Cucamonga,  CA  91730
Correspondent Contact Owen J. Bry
Regulation Number870.5800
Classification Product Code
JOW  
Date Received11/19/2014
Decision Date 01/20/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-