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 Syringe, Piston
510(k) Number K951918
Device Name SURGICAL TECHNOLOGIES, INC. SYRINGE
Applicant
Surgical Technologies, Inc.
2801 S. Decker Lake Ln.
Salt Lake City,  UT  84119
Applicant Contact JOHN E LINCOLN
Correspondent
Surgical Technologies, Inc.
2801 S. Decker Lake Ln.
Salt Lake City,  UT  84119
Correspondent Contact JOHN E LINCOLN
Regulation Number880.5860
Classification Product Code
FMF  
Date Received04/24/1995
Decision Date 07/20/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-