The following data is part of a premarket notification filed by Endovations with the FDA for Endovations(r) .035 Pre-cut Papillatome.
| Device ID | K934315 |
| 510k Number | K934315 |
| Device Name: | ENDOVATIONS(R) .035 PRE-CUT PAPILLATOME |
| Classification | Unit, Electrosurgical, Endoscopic (with Or Without Accessories) |
| Applicant | ENDOVATIONS HILL AND GEORGE AVENUES P.O. BOX 6386 Reading, PA 19610 |
| Contact | Ronald D Wolfe |
| Correspondent | Ronald D Wolfe ENDOVATIONS HILL AND GEORGE AVENUES P.O. BOX 6386 Reading, PA 19610 |
| Product Code | KNS |
| CFR Regulation Number | 876.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-09-01 |
| Decision Date | 1994-02-28 |