The following data is part of a premarket notification filed by Proact, Ltd. with the FDA for Bone-temno/sternum-temno.
| Device ID | K913306 |
| 510k Number | K913306 |
| Device Name: | BONE-TEMNO/STERNUM-TEMNO |
| Classification | Bone Marrow Collection/transfusion Kit |
| Applicant | PROACT, LTD. CALDER SQUARE BOX 11029 State College, PA 16805 |
| Contact | Joseph M Looney |
| Correspondent | Joseph M Looney PROACT, LTD. CALDER SQUARE BOX 11029 State College, PA 16805 |
| Product Code | LWE |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-07-25 |
| Decision Date | 1991-11-01 |