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 K953254
Device Name STRATO/INFUSAID INFUSE-A-KIT
Applicant
Strato/Infusaid, Inc.
1400 Providence Hwy.
Norwood,  MA  02062
Applicant Contact CRAIG M AUDET
Correspondent
Strato/Infusaid, Inc.
1400 Providence Hwy.
Norwood,  MA  02062
Correspondent Contact CRAIG M AUDET
Regulation Number880.5965
Classification Product Code
LJT  
Date Received07/12/1995
Decision Date 11/29/1995
Decision Substantially Equivalent - Kit (SESK)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-