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 needle, aspiration and injection, reusable
510(k) Number K936207
Device Name ENDO-NEEDLE INSTRUMENT
Applicant
GERARD MEDICAL, INC.
90 WORCESTER RD.
CHARLTON,  MA  01507
Applicant Contact RICHARD CAYER, JR.
Correspondent
GERARD MEDICAL, INC.
90 WORCESTER RD.
CHARLTON,  MA  01507
Correspondent Contact RICHARD CAYER, JR.
Regulation Number878.4800
Classification Product Code
GDM  
Date Received12/29/1993
Decision Date 06/16/1994
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
-
-