The following data is part of a premarket notification filed by Friadent Gmbh with the FDA for Frios Algipore.
Device ID | K023799 |
510k Number | K023799 |
Device Name: | FRIOS ALGIPORE |
Classification | Bone Grafting Material, Synthetic |
Applicant | FRIADENT GMBH 21911 ERIE LN. Lake Forest, CA 92630 |
Contact | Carol Patterson |
Correspondent | Carol Patterson FRIADENT GMBH 21911 ERIE LN. Lake Forest, CA 92630 |
Product Code | LYC |
CFR Regulation Number | 872.3930 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2002-11-14 |
Decision Date | 2003-02-05 |
Summary: | summary |