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 K875082
Device Name O.P.C. INTRAVASCULAR CATHETER
Applicant
Taut, Inc.
2571 Kaneville Ct.
Geneva,  IL  60134
Applicant Contact R. D KENSETH
Correspondent
Taut, Inc.
2571 Kaneville Ct.
Geneva,  IL  60134
Correspondent Contact R. D KENSETH
Regulation Number880.5200
Classification Product Code
FOZ  
Date Received12/09/1987
Decision Date 03/08/1988
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
-
-