The following data is part of a premarket notification filed by R And D Medical, Llc with the FDA for Formagraft Collagen Bone Graft Matrix.
Device ID | K050789 |
510k Number | K050789 |
Device Name: | FORMAGRAFT COLLAGEN BONE GRAFT MATRIX |
Classification | Filler, Bone Void, Calcium Compound |
Applicant | R AND D MEDICAL, LLC 4329 GRAYDON ROAD San Diego, CA 92130 |
Contact | Floyd G Larson |
Correspondent | Floyd G Larson R AND D MEDICAL, LLC 4329 GRAYDON ROAD San Diego, CA 92130 |
Product Code | MQV |
CFR Regulation Number | 888.3045 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2005-03-28 |
Decision Date | 2005-05-27 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00887517239372 | K050789 | 000 |
00887517239365 | K050789 | 000 |
00887517239310 | K050789 | 000 |
00887517238450 | K050789 | 000 |
00887517238443 | K050789 | 000 |
00887517238436 | K050789 | 000 |
00887517238412 | K050789 | 000 |
00887517238429 | K050789 | 000 |
00887517237392 | K050789 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
FORMAGRAFT COLLAGEN BONE GRAFT MATRIX 78825910 not registered Dead/Abandoned |
Radius Medical, LLC 2006-02-28 |