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 Dispenser, Solid Medication
510(k) Number K944481
Device Name THE HEART PROTECTOR
Applicant
Garan Scientific, Inc.
P.O. Box 1396
Morristown,  NJ  07960
Applicant Contact GARY STERN
Correspondent
Garan Scientific, Inc.
P.O. Box 1396
Morristown,  NJ  07960
Correspondent Contact GARY STERN
Regulation Number890.5050
Classification Product Code
NXB  
Date Received09/13/1994
Decision Date 04/10/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-