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, Intravascular, Therapeutic, Short-Term Less Than 30 Days
510(k) Number K933050
Device Name CHANGES TO PROTECTIV(TM) & JELCO(TM) WINGED CATH
Applicant
Critikon Company, LLC
4110 George Rd.
P.O. Box 31800
Tampa,  FL  33631
Applicant Contact JOHN S SAMORAJCZYK
Correspondent
Critikon Company, LLC
4110 George Rd.
P.O. Box 31800
Tampa,  FL  33631
Correspondent Contact JOHN S SAMORAJCZYK
Regulation Number880.5200
Classification Product Code
FOZ  
Date Received05/20/1993
Decision Date 12/14/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-