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 Endoscopic Grasping/Cutting Instrument, Non-Powered
510(k) Number K942030
Device Name BIOPSY SCISSORS
Applicant
Surgical Technologies, Inc.
4715 NW 157th. St.,
Suite 124
Miami Lakes,  FL  33014
Applicant Contact LASZLO FAZEKAS
Correspondent
Surgical Technologies, Inc.
4715 NW 157th. St.,
Suite 124
Miami Lakes,  FL  33014
Correspondent Contact LASZLO FAZEKAS
Regulation Number876.1500
Classification Product Code
OCZ  
Subsequent Product Code
FCF  
Date Received04/26/1994
Decision Date 06/27/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-