The following data is part of a premarket notification filed by Synthes Usa Products, Llc with the FDA for Synthes Hemostatic Bone Putty (hbp).
Device ID | K103822 |
510k Number | K103822 |
Device Name: | SYNTHES HEMOSTATIC BONE PUTTY (HBP) |
Classification | Wax, Bone |
Applicant | SYNTHES USA PRODUCTS, LLC 1230 WILSON BLVD. West Chester, PA 19380 |
Contact | Jeffrey L Dow |
Correspondent | Jeffrey L Dow SYNTHES USA PRODUCTS, LLC 1230 WILSON BLVD. West Chester, PA 19380 |
Product Code | MTJ |
CFR Regulation Number | 510(k) Premarket Notification [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2010-12-30 |
Decision Date | 2011-05-19 |
Summary: | summary |