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, irrigation
510(k) Number K844876
Device Name PENNINE NELATON CATHETERS SIZES 5,6,8,10,12,14,16,
Applicant
PENNINE MEDICAL LTD.
PONTEFRACT ST.ASCOT
DR.IND.ESATE
DERBY,  GB
Applicant Contact TERRY MORGAN
Correspondent
PENNINE MEDICAL LTD.
PONTEFRACT ST.ASCOT
DR.IND.ESATE
DERBY,  GB
Correspondent Contact TERRY MORGAN
Regulation Number878.4200
Classification Product Code
GBX  
Date Received12/17/1984
Decision Date 06/05/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-