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 K864781
Device Name MACLEE/BOIN MEDICA STERILE NEEDLE/SYRINGE 20ML/CC
Applicant
Mac Lee Medical Products
2900 SW Atwood
Topeka,  KS  66614
Applicant Contact GEORGE E LIESMANN
Correspondent
Mac Lee Medical Products
2900 SW Atwood
Topeka,  KS  66614
Correspondent Contact GEORGE E LIESMANN
Regulation Number880.5860
Classification Product Code
FMF  
Date Received12/08/1986
Decision Date 12/29/1986
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
-
-