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 K923260
Device Name LAPAROSCOPY SETS, NEEDLE HOLDERS, BLUNT CURVED
Applicant
Imtec Corp.
3071 Continental Dr.
West Palm Baeach,  FL  33407
Applicant Contact MARK C HAMBLIN
Correspondent
Imtec Corp.
3071 Continental Dr.
West Palm Baeach,  FL  33407
Correspondent Contact MARK C HAMBLIN
Regulation Number884.1720
Classification Product Code
HET  
Date Received07/02/1992
Decision Date 06/09/1994
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
-
-