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 Pump, Infusion
510(k) Number K894028
Device Name AMBULATORY INFUSION SYSTEM AND ACCESSORIES
Applicant
Patient Solutions, Inc.
13220 Evening Creek Dr. So.,
Suite 114
San Diego,  CA  92128
Applicant Contact DAVID L DAVIS
Correspondent
Patient Solutions, Inc.
13220 Evening Creek Dr. So.,
Suite 114
San Diego,  CA  92128
Correspondent Contact DAVID L DAVIS
Regulation Number880.5725
Classification Product Code
FRN  
Date Received06/06/1989
Decision Date 12/22/1989
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
-
-