The following data is part of a premarket notification filed by Biologic Therapies Inc with the FDA for Intraosseous Cannula System Bio-mac¿ And Bio-core.
| Device ID | K141910 |
| 510k Number | K141910 |
| Device Name: | Intraosseous Cannula System Bio-MAC¿ And Bio-CORE |
| Classification | Instrument, Biopsy |
| Applicant | BIOLOGIC THERAPIES INC 3150 E. 200TH ST. Prior Lake, MN 55372 |
| Contact | Al Lippincott |
| Correspondent | Stephen Inglese BIOLOGIC THERAPIES INC 5817 NW 44th Ave Ocala, FL 34482 |
| Product Code | KNW |
| CFR Regulation Number | 876.1075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-07-15 |
| Decision Date | 2015-05-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M896LTN45O1 | K141910 | 000 |
| M896LTN25O1 | K141910 | 000 |
| M896LTN105O1 | K141910 | 000 |