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 Binder, Elastic
510(k) Number K882592
Device Name HEART HUGGER STERNUM SUPPORT HARNESS
Applicant
General Cardiac Technology, Inc.
795 Carmel Ave.
Suite 3
Sunnyvale,  CA  94086
Applicant Contact WILLIAMS, JR
Correspondent
General Cardiac Technology, Inc.
795 Carmel Ave.
Suite 3
Sunnyvale,  CA  94086
Correspondent Contact WILLIAMS, JR
Regulation Number880.5160
Classification Product Code
KMO  
Date Received06/23/1988
Decision Date 09/20/1988
Decision Substantially Equivalent (SESE)
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
-
-