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 Laparoscope, Gynecologic (And Accessories)
510(k) Number K941507
FOIA Releasable 510(k) K941507
Device Name THEMO-FLO SYSTEM 3 LAPAROSCOPIC/HYSTEROSCOPIC SYSTEM
Applicant
SANESE MEDICAL CORP.
885 NORTHWEST BLVD.
COLUMBUS,  OH  43212
Applicant Contact CHRISTOPHER N SANESE
Correspondent
SANESE MEDICAL CORP.
885 NORTHWEST BLVD.
COLUMBUS,  OH  43212
Correspondent Contact CHRISTOPHER N SANESE
Regulation Number884.1720
Classification Product Code
HET  
Date Received03/29/1994
Decision Date 03/06/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-