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 set, administration, intravascular
510(k) Number K894787
Device Name MEL-PAK GENERAL DRUG DELIVERY SYSTEM KIT
Applicant
NEW YORK BLOOD CENTER, INC.
BOX 5119
155 DURYEA ROAD
MELVILLE,  NY  11747
Applicant Contact MARTIN H STRYKER
Correspondent
NEW YORK BLOOD CENTER, INC.
BOX 5119
155 DURYEA ROAD
MELVILLE,  NY  11747
Correspondent Contact MARTIN H STRYKER
Regulation Number880.5440
Classification Product Code
FPA  
Date Received07/31/1989
Decision Date 09/13/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-