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 Port & Catheter, Implanted, Subcutaneous, Intravascular
510(k) Number K953529
Device Name STRATO/INFUSAID LIFE & INFUSE-A-PORT IMPLANTABLE PORT SYSTEM
Applicant
STRATO/INFUSAID, INC.
1400 PROVIDENCE HIGHWAY
NORWOOD,  MA  02062
Applicant Contact CRAIG M AUDET
Correspondent
STRATO/INFUSAID, INC.
1400 PROVIDENCE HIGHWAY
NORWOOD,  MA  02062
Correspondent Contact CRAIG M AUDET
Regulation Number880.5965
Classification Product Code
LJT  
Date Received07/27/1995
Decision Date 01/26/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-