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 K990518
Device Name PEREGRINE WET SET, MODEL PD400.00
Applicant
Peregrine Surgical , Ltd.
4050 D Skyron Dr.
Doylestown,  PA  18901
Applicant Contact JOHN E RICHMOND
Correspondent
Peregrine Surgical , Ltd.
4050 D Skyron Dr.
Doylestown,  PA  18901
Correspondent Contact JOHN E RICHMOND
Regulation Number880.5725
Classification Product Code
FRN  
Date Received02/18/1999
Decision Date 03/25/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-