EQUIMATRIX
Bone Grafting Material, Animal Source
LUITPOLD PHARMACEUTICALS, INC.
The following data is part of a premarket notification filed by Luitpold Pharmaceuticals, Inc. with the FDA for Equimatrix.
Pre-market Notification Details
| Device ID | K111816 |
| 510k Number | K111816 |
| Device Name: | EQUIMATRIX |
| Classification | Bone Grafting Material, Animal Source |
| Applicant | LUITPOLD PHARMACEUTICALS, INC. ONE LUITPOLD DR. P.O. BOX 9001 Shirley, NY 11967 |
| Contact | Marsha Simon |
| Correspondent | Marsha Simon LUITPOLD PHARMACEUTICALS, INC. ONE LUITPOLD DR. P.O. BOX 9001 Shirley, NY 11967 |
| Product Code | NPM |
| CFR Regulation Number | 872.3930 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-06-27 |
| Decision Date | 2011-09-29 |
| Summary: | summary |
Trademark Results [EQUIMATRIX]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 EQUIMATRIX 85102946 4115733 Live/Registered |
AMERICAN REGENT, INC. 2010-08-09 |
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