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 K852444
Device Name ASIK 'ONCE' SYRINGE
Applicant
Pharma-Plast USA, Inc.
1801 Mcgill College Ave.
Suite 1470, Montreal
Canada H3a 2n4,  CA
Applicant Contact DOUGLAS M BENNETT
Correspondent
Pharma-Plast USA, Inc.
1801 Mcgill College Ave.
Suite 1470, Montreal
Canada H3a 2n4,  CA
Correspondent Contact DOUGLAS M BENNETT
Regulation Number880.5860
Classification Product Code
FMF  
Date Received06/10/1985
Decision Date 10/16/1985
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
-
-