The following data is part of a premarket notification filed by Davol, Inc., Sub. C.r. Bard, Inc. with the FDA for Nezhat-dorsey Reusable Electrosurgical Attachments: J-hook Tip, L-hook Tip, Corbitt Spatula Tip, Needle Tip, Ball Tip.
| Device ID | K003674 |
| 510k Number | K003674 |
| Device Name: | NEZHAT-DORSEY REUSABLE ELECTROSURGICAL ATTACHMENTS: J-HOOK TIP, L-HOOK TIP, CORBITT SPATULA TIP, NEEDLE TIP, BALL TIP |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | DAVOL, INC., SUB. C.R. BARD, INC. 100 SOCKANOSSETT CROSSROAD Cranston, RI 02920 |
| Contact | Ruth C Forstadt |
| 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 | 2000-11-29 |
| Decision Date | 2000-12-08 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00801741077258 | K003674 | 000 |
| 00801741077241 | K003674 | 000 |
| 00801741077234 | K003674 | 000 |
| 00801741077227 | K003674 | 000 |
| 10801741077149 | K003674 | 000 |