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 scalpel, one-piece
510(k) Number K923689
Device Name SURGISTAR BLADES
Applicant
SURGISTAR, INC.
P.O. BOX 2722
VISTA,  CA  92085
Applicant Contact JONATHAN WOODWARD
Correspondent
SURGISTAR, INC.
P.O. BOX 2722
VISTA,  CA  92085
Correspondent Contact JONATHAN WOODWARD
Regulation Number878.4800
Classification Product Code
GDX  
Date Received07/24/1992
Decision Date 09/09/1992
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
-
-