The following data is part of a premarket notification filed by Medi-globe Corp. with the FDA for Gip/medi-globe Papillotome.
| Device ID | K943629 |
| 510k Number | K943629 |
| Device Name: | GIP/MEDI-GLOBE PAPILLOTOME |
| Classification | Unit, Electrosurgical, Endoscopic (with Or Without Accessories) |
| Applicant | MEDI-GLOBE CORP. 6202 SOUTH MAPLE AVE. # 131 Tempe, AZ 85283 |
| Contact | Brian Karler |
| Correspondent | Brian Karler MEDI-GLOBE CORP. 6202 SOUTH MAPLE AVE. # 131 Tempe, AZ 85283 |
| Product Code | KNS |
| CFR Regulation Number | 876.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-07-26 |
| Decision Date | 1995-05-26 |