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 Surgical Instruments, G-U, Manual (And Accessories)
510(k) Number K921546
Device Name VASOVASOSTOMY SET
Applicant
Cook Urological, Inc.
1100 W. Morgan St.
P.O. Box 227
Spencer,  IN  47460
Applicant Contact TAMMY BACON
Correspondent
Cook Urological, Inc.
1100 W. Morgan St.
P.O. Box 227
Spencer,  IN  47460
Correspondent Contact TAMMY BACON
Regulation Number876.4730
Classification Product Code
KOA  
Date Received04/01/1992
Decision Date 07/02/1993
Decision Substantially Equivalent - Kit (SESK)
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
-
-