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) | Registration & Listing | Adverse Events | Recalls | PMA | 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, animal source
510(K) Number K122894
Model 20111, 20112, 20113, 20114, 20121, 20122, 20131, 20141, 20142, 20143, 20146, 20147, 20115
Device Name GEISTLICH BIO-OSS, GEISTLICH BIO-OSS COLLAGEN, GEISTLICH COMBI-KIT COLLAGEN, GEISTLICH PERIO SYSTEM COMBI PACK, GEISTLIC
Applicant
GEISTLICH PHARMA AG
555 twelfth street, nw
washington,  DC  20004 1206
Contact daniel a kracov
Regulation Number872.3930
Classification Product Code
NPM  
Date Received09/21/2012
Decision Date 02/15/2013
Decision substantially equivalent (SE)
Classification Advisory Committee Dental
Review Advisory Committee Dental
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
-
-