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 Coagulator-Cutter, Endoscopic, Unipolar (And Accessories)
510(k) Number K933300
Device Name GEISTER SURGICAL INT'L MONOPOLAR ENDOSCOPIC SURG.INST.
Applicant
Lyle Howard Corp.
Round Valley Plz.
Suite 304
Lebanon,  NJ  08833
Applicant Contact LYNETTE HOWARD
Correspondent
Lyle Howard Corp.
Round Valley Plz.
Suite 304
Lebanon,  NJ  08833
Correspondent Contact LYNETTE HOWARD
Regulation Number884.4160
Classification Product Code
KNF  
Date Received07/07/1993
Decision Date 09/30/1994
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
-
-