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 Apparatus, Autotransfusion
510(k) Number K993581
Device Name HAEMONETICS LN 193 DISPOSABLE SET, FOR USE WITH THE HAEMONETICS CELLSEVER HAEMOLITE 2 FAMILY OF AUTOLOGOUS BLOOD RECOVER
Applicant
Haemonetics Corp.
400 Wood Rd.
P.O. Box 9114
Braintree,  MA  02184
Applicant Contact ALICIA R LOPEZ
Correspondent
Haemonetics Corp.
400 Wood Rd.
P.O. Box 9114
Braintree,  MA  02184
Correspondent Contact ALICIA R LOPEZ
Regulation Number868.5830
Classification Product Code
CAC  
Date Received10/22/1999
Decision Date 11/18/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-