The following data is part of a premarket notification filed by Biomedical International Corp. with the FDA for Bone & Marrow Cllection System.
| Device ID | K971268 |
| 510k Number | K971268 |
| Device Name: | BONE & MARROW CLLECTION SYSTEM |
| Classification | Motor, Surgical Instrument, Ac-powered |
| Applicant | BIOMEDICAL INTERNATIONAL CORP. 14785 OMICRON, DR. San Antonio, TX 78245 |
| Contact | Casey Fox |
| Correspondent | Casey Fox BIOMEDICAL INTERNATIONAL CORP. 14785 OMICRON, DR. San Antonio, TX 78245 |
| Product Code | GEY |
| CFR Regulation Number | 878.4820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-04-07 |
| Decision Date | 1997-07-03 |