• 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 K931501
Device Name NUMED DISPOSABLE ATT. NUMED HANDLE LAP. INST.
Applicant
NUMED TECHNOLOGIES, INC.
5755 GRANGER RD.
INDEPENDENCE,  OH  44131
Applicant Contact JAN LEWANDOWSKI
Correspondent
NUMED TECHNOLOGIES, INC.
5755 GRANGER RD.
INDEPENDENCE,  OH  44131
Correspondent Contact JAN LEWANDOWSKI
Regulation Number884.1720
Classification Product Code
HET  
Date Received03/25/1993
Decision Date 01/11/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-