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, Animal Source
510(k) Number K170541
Device Name Anorganic Bone Mineral in Delivery Applicator
Applicant
Collagen Matrix, Inc.
15 Thornton Road
Oakland,  NJ  07436
Applicant Contact Danielle Lindner
Correspondent
Collagen Matrix, Inc.
15 Thornton Road
Oakland,  NJ  07436
Correspondent Contact Danielle Lindner
Regulation Number872.3930
Classification Product Code
NPM  
Date Received02/23/2017
Decision Date 07/07/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-