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 tape and bandage, adhesive
510(k) Number K924192
Device Name I.V. START KIT (AHC-50-54954
Applicant
AMERICAN HEALTHCARE CORP.
ONE AMERICAN HEALTHCARE PLAZA
3611 KENNEDY ROAD
SOUTH PLAINFIELD,  NJ  07080
Applicant Contact RALPH S JARRETT
Correspondent
AMERICAN HEALTHCARE CORP.
ONE AMERICAN HEALTHCARE PLAZA
3611 KENNEDY ROAD
SOUTH PLAINFIELD,  NJ  07080
Correspondent Contact RALPH S JARRETT
Regulation Number880.5240
Classification Product Code
KGX  
Subsequent Product Code
LRS  
Date Received08/20/1992
Decision Date 08/27/1993
Decision Substantially Equivalent - Kit With Drugs (SEKD)
Regulation Medical Specialty General Hospital
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-