The following data is part of a premarket notification filed by Mahe Intl., Inc. with the FDA for Mahe Instruments.
| Device ID | K942823 |
| 510k Number | K942823 |
| Device Name: | MAHE INSTRUMENTS |
| Classification | Electrosurgical Device |
| Applicant | MAHE INTL., INC. 300 JAMES ROBERTSON PKWY. Nashville, TN 37201 |
| Contact | Winfried Reich |
| Correspondent | Winfried Reich MAHE INTL., INC. 300 JAMES ROBERTSON PKWY. Nashville, TN 37201 |
| Product Code | DWG |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-06-14 |
| Decision Date | 1994-12-05 |