The following data is part of a premarket notification filed by V. Mueller Neuro/spine with the FDA for Ultra-line Rongeur.
| Device ID | K943635 |
| 510k Number | K943635 |
| Device Name: | ULTRA-LINE RONGEUR |
| Classification | Rongeur, Manual |
| Applicant | V. MUELLER NEURO/SPINE 871 INDUSTRIAL RD. San Carlos, CA 94070 |
| Contact | Terry Johnston |
| Correspondent | Terry Johnston V. MUELLER NEURO/SPINE 871 INDUSTRIAL RD. San Carlos, CA 94070 |
| Product Code | HAE |
| CFR Regulation Number | 882.4840 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-07-27 |
| Decision Date | 1994-12-07 |