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 Collector, Urine, (And Accessories) For Indwelling Catheter
510(k) Number K935557
Device Name URINARY DRAINAGE BAG
Applicant
Puritas Health Care, Inc.
219 Kent Rd.,
Suite 20
New Milford,  CT  06776
Applicant Contact THOMAS P DIMAIO
Correspondent
Puritas Health Care, Inc.
219 Kent Rd.,
Suite 20
New Milford,  CT  06776
Correspondent Contact THOMAS P DIMAIO
Regulation Number876.5250
Classification Product Code
KNX  
Date Received11/17/1993
Decision Date 03/07/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-