The following data is part of a premarket notification filed by Aesculap, Inc. with the FDA for Mri Safe Instruments.
| Device ID | K003965 |
| 510k Number | K003965 |
| Device Name: | MRI SAFE INSTRUMENTS |
| Classification | Cannula, Surgical, General & Plastic Surgery |
| Applicant | AESCULAP, INC. 944 MARCON BLVD. Allentown, PA 18109 |
| Contact | Lisa M Millington |
| Correspondent | Lisa M Millington AESCULAP, INC. 944 MARCON BLVD. Allentown, PA 18109 |
| Product Code | GEA |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-12-22 |
| Decision Date | 2001-03-16 |