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 Catheter, Peritoneal, Long-Term Indwelling
510(k) Number K863128
Device Name PERITONEAL DIALYSIS CATHETERS
Applicant
Thermedics, Inc.
470 Wildwood St.
P.O. Box 2697
Woburn,  MA  01888
Applicant Contact ROBERT MURFITT
Correspondent
Thermedics, Inc.
470 Wildwood St.
P.O. Box 2697
Woburn,  MA  01888
Correspondent Contact ROBERT MURFITT
Regulation Number876.5630
Classification Product Code
FJS  
Date Received08/15/1986
Decision Date 09/09/1986
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
-
-