The following data is part of a premarket notification filed by Mahe Intl., Inc. with the FDA for Mahe Instruments.
| Device ID | K991426 |
| 510k Number | K991426 |
| Device Name: | MAHE INSTRUMENTS |
| Classification | Resectoscope, Working Element |
| Applicant | MAHE INTL., INC. 300 JAMES ROBERTSON PKWY. Nashville, TN 37201 |
| Contact | Winifried Reich |
| Correspondent | Winifried Reich MAHE INTL., INC. 300 JAMES ROBERTSON PKWY. Nashville, TN 37201 |
| Product Code | FDC |
| Subsequent Product Code | FAS |
| Subsequent Product Code | FJL |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-04-23 |
| Decision Date | 1999-08-05 |
| Summary: | summary |