• 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, Hypodermic, Single Lumen
510(k) Number K952834
Device Name SHROUDED PLASTIC CANNULA
Applicant
Medical Associates Network, Inc.
10572 Mahoney Dr.
Sunland,  CA  91040
Applicant Contact ROBERT T MERRICK
Correspondent
Medical Associates Network, Inc.
10572 Mahoney Dr.
Sunland,  CA  91040
Correspondent Contact ROBERT T MERRICK
Regulation Number880.5570
Classification Product Code
FMI  
Date Received06/20/1995
Decision Date 10/03/1995
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
-
-