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 Electrocautery, Gynecologic (And Accessories)
510(k) Number K003608
Device Name SOVEREIGN BIPOLAR INSTRUMENTS FOR GYNECOLOGY
Applicant
AESCULAP, INC.
944 MARCON BLVD.
ALLENTOWN,  PA  18109
Applicant Contact LISA M MILLINGTON
Correspondent
AESCULAP, INC.
944 MARCON BLVD.
ALLENTOWN,  PA  18109
Correspondent Contact LISA M MILLINGTON
Regulation Number884.4120
Classification Product Code
HGI  
Date Received11/22/2000
Decision Date 02/20/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-