• 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 K042405
Device Name PAINPUMP1; PAINPUMP2
Applicant
STRYKER CORP.
4100 E. MILHAM AVE.
KALAMAZOO,  MI  49001
Applicant Contact JENNIFER MARS
Correspondent
STRYKER CORP.
4100 E. MILHAM AVE.
KALAMAZOO,  MI  49001
Correspondent Contact JENNIFER MARS
Regulation Number880.5725
Classification Product Code
FRN  
Date Received09/03/2004
Decision Date 10/14/2004
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
Recalls CDRH Recalls
-
-