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 Control, Red-Cell
510(k) Number K940430
Device Name SEDRATROL
Applicant
Medical Specialties Intl., Inc.
3610 Kennedy Rd.
South Plainfield,  NJ  07080
Applicant Contact W. KEVIN LIDDLE
Correspondent
Medical Specialties Intl., Inc.
3610 Kennedy Rd.
South Plainfield,  NJ  07080
Correspondent Contact W. KEVIN LIDDLE
Regulation Number864.8625
Classification Product Code
GJR  
Date Received01/31/1994
Decision Date 02/06/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-