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 Kit, Repair, Catheter, Hemodialysis
510(k) Number K022570
Device Name MEDCOMP REPAIR KIT, MODEL ASPCRPK
Applicant
Medcomp
1499 Delp Dr.
Harleysville,  PA  19438
Applicant Contact FLORENCE A CAIKOSKI
Correspondent
Medcomp
1499 Delp Dr.
Harleysville,  PA  19438
Correspondent Contact FLORENCE A CAIKOSKI
Regulation Number876.5540
Classification Product Code
NFK  
Date Received08/02/2002
Decision Date 10/31/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
-
-