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 Pad, Alcohol, Device Disinfectant
510(k) Number K132380
Device Name PREVANTICS DEVICE SWAB
Applicant
Professional Disposables International, Inc.
2 Nice Pak Park
Orangeburg,  NY  10962
Applicant Contact ELIZABETH ERNST
Correspondent
Professional Disposables International, Inc.
2 Nice Pak Park
Orangeburg,  NY  10962
Correspondent Contact ELIZABETH ERNST
Classification Product Code
LKB  
Date Received07/31/2013
Decision Date 08/27/2014
Decision Substantially Equivalent (SESE)
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-