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 Cerclage, Fixation
510(k) Number K930015
Device Name STERNAL BAND
Applicant
Stony Brook Surgical Innovations, Inc.
55 Northern Blvd., Suite 301
Great Neck,  NY  11021
Applicant Contact ANAND AKERKAR
Correspondent
Stony Brook Surgical Innovations, Inc.
55 Northern Blvd., Suite 301
Great Neck,  NY  11021
Correspondent Contact ANAND AKERKAR
Regulation Number888.3010
Classification Product Code
JDQ  
Date Received01/04/1993
Decision Date 05/19/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-