• 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 coagulator, laparoscopic, unipolar (and accessories)
510(k) Number K915406
Device Name DAVOL ELECTROSUGICAL PROBES
Applicant
DAVOL, INC.
100 SOCKANOSSETT CROSSROAD
P.O. BOX 8500
CRANSTON,  RI  02920
Applicant Contact ROBIN DARGO
Correspondent
DAVOL, INC.
100 SOCKANOSSETT CROSSROAD
P.O. BOX 8500
CRANSTON,  RI  02920
Correspondent Contact ROBIN DARGO
Regulation Number884.4160
Classification Product Code
HFG  
Date Received12/02/1991
Decision Date 02/28/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-