The following data is part of a premarket notification filed by C.r. Bard, Inc. with the FDA for Advantage Single-use Electrosurgical Attachment-j-hook Tip, L-hook Tip, Corbitt Spatula Tip, Ball Tip, Needle Tip.
| Device ID | K010444 |
| 510k Number | K010444 |
| Device Name: | ADVANTAGE SINGLE-USE ELECTROSURGICAL ATTACHMENT-J-HOOK TIP, L-HOOK TIP, CORBITT SPATULA TIP, BALL TIP, NEEDLE TIP |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | C.R. BARD, INC. 700 EAST 22ND ST. Lawrence, KS |
| Contact | Kerry Chunko |
| Correspondent | Robert Mosenkis CITECH 5200 BUTLER PIKE Plymouth Meeting, PA 19462 -1298 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2001-02-14 |
| Decision Date | 2001-02-28 |