The following data is part of a premarket notification filed by Boss Instruments, Ltd. with the FDA for Koala Vascular Clamps And Inserts.
| Device ID | K980002 |
| 510k Number | K980002 |
| Device Name: | KOALA VASCULAR CLAMPS AND INSERTS |
| Classification | Clamp, Vascular |
| Applicant | BOSS INSTRUMENTS, LTD. 1310 CENTRAL CT. Hermitage, TN 37076 |
| Contact | Burns Phillips |
| Correspondent | Burns Phillips BOSS INSTRUMENTS, LTD. 1310 CENTRAL CT. Hermitage, TN 37076 |
| Product Code | DXC |
| CFR Regulation Number | 870.4450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-01-02 |
| Decision Date | 1998-06-18 |
| Summary: | summary |