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 Bone Grafting Material, Synthetic
510(k) Number K923310
Device Name OSTEOGEN (HA RESORB)
Applicant
Impladent
198-45 Foothill Ave.
Hollis,  NY  11423
Applicant Contact MAURICE VALEN
Correspondent
Impladent
198-45 Foothill Ave.
Hollis,  NY  11423
Correspondent Contact MAURICE VALEN
Regulation Number872.3930
Classification Product Code
LYC  
Date Received07/07/1992
Decision Date 05/31/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-