• 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 bone grafting material, synthetic
510(k) Number K192597
Device Name Cytrans Granules
Applicant
GC America, Inc.
3737 W. 127th St.
Alsip,  IL  60803
Applicant Contact Mark Heiss
Correspondent
Wood Burditt Group
10 E. Scranton Ave., Ste. 201
Lake Bluff,  IL  60045
Correspondent Contact H. Carl Jenkins
Regulation Number872.3930
Classification Product Code
LYC  
Date Received09/20/2019
Decision Date 08/17/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
-
-