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 Wound Drain Catheter System
510(k) Number K150042
FOIA Releasable 510(k) K150042
Device Name PleuraFlow System
Applicant
Clearflow, Inc.
1630 S. Sunkist St. Suite E
Anaheim,  CA  92806
Applicant Contact Dov Gal
Correspondent
Clearflow, Inc.
1630 S. Sunkist St. Suite E
Anaheim,  CA  92806
Correspondent Contact Dov Gal
Regulation Number878.4780
Classification Product Code
OTK  
Date Received01/09/2015
Decision Date 06/02/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-