The following data is part of a premarket notification filed by Mahe-medizintechnik with the FDA for Mahe Instruments.
| Device ID | K935442 |
| 510k Number | K935442 |
| Device Name: | MAHE INSTRUMENTS |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | MAHE-MEDIZINTECHNIK 300 JAMES ROBERTSON PKWY. Nashville, TN 37201 |
| Contact | Winfried Reich |
| Correspondent | Winfried Reich MAHE-MEDIZINTECHNIK 300 JAMES ROBERTSON PKWY. Nashville, TN 37201 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-11-12 |
| Decision Date | 1994-03-14 |