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 Guide, Needle, Surgical
510(k) Number K863090
Device Name PERCU GUIDE I (LOOP TYPE)
Applicant
E-Z-Em, Inc.
717 Main St.
Westbury,  NY  11590
Applicant Contact JACK T BERGER
Correspondent
E-Z-Em, Inc.
717 Main St.
Westbury,  NY  11590
Correspondent Contact JACK T BERGER
Regulation Number878.4800
Classification Product Code
GDF  
Date Received08/13/1986
Decision Date 08/29/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-