The following data is part of a premarket notification filed by Geistlich-pharma with the FDA for Resor-pin Resorbable Membrane Pin.
Device ID | K972817 |
510k Number | K972817 |
Device Name: | RESOR-PIN RESORBABLE MEMBRANE PIN |
Classification | Bone Grafting Material, Synthetic |
Applicant | GEISTLICH-PHARMA 1050 CONNECTICUT AVE. N.W. Washington, DC 20036 |
Contact | Peter S Reichertz |
Correspondent | Peter S Reichertz GEISTLICH-PHARMA 1050 CONNECTICUT AVE. N.W. Washington, DC 20036 |
Product Code | LYC |
CFR Regulation Number | 872.3930 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1997-07-29 |
Decision Date | 1998-07-24 |