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 K041991
Device Name ASPIREX - BONE MARROW ASPIRATE KIT
Applicant
Isotis Orthobiologics, Inc.
2 Goodyear, Suite B
Irvine,  CA  92618
Applicant Contact PAUL DONER
Correspondent
Isotis Orthobiologics, Inc.
2 Goodyear, Suite B
Irvine,  CA  92618
Correspondent Contact PAUL DONER
Regulation Number880.5860
Classification Product Code
FMF  
Date Received07/23/2004
Decision Date 09/16/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-