The following data is part of a premarket notification filed by Medi-globe Corporation with the FDA for Medi-globe Rota-cut Sphincterotome.
| Device ID | K061684 |
| 510k Number | K061684 |
| Device Name: | MEDI-GLOBE ROTA-CUT SPHINCTEROTOME |
| Classification | Unit, Electrosurgical, Endoscopic (with Or Without Accessories) |
| Applicant | MEDI-GLOBE CORPORATION 110 WEST ORION #136 Tempe, AZ 85248 |
| Contact | Scott Karler |
| Correspondent | Daniel W Lehtonen INTERTEK TESTING SERVICES 2307 EAST AURORA ROAD UNIT B7 Twinsburg, OH 44087 |
| Product Code | KNS |
| CFR Regulation Number | 876.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2006-06-15 |
| Decision Date | 2006-06-27 |
| Summary: | summary |