The following data is part of a premarket notification filed by River Medical, Inc. with the FDA for River Medical Microdrill System.
| Device ID | K905437 |
| 510k Number | K905437 |
| Device Name: | RIVER MEDICAL MICRODRILL SYSTEM |
| Classification | Source, Carrier, Fiberoptic Light |
| Applicant | RIVER MEDICAL, INC. P.O.BOX 30517 Memphis, TN 38130 |
| Contact | George Murray |
| Correspondent | George Murray RIVER MEDICAL, INC. P.O.BOX 30517 Memphis, TN 38130 |
| Product Code | EQH |
| CFR Regulation Number | 874.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-12-04 |
| Decision Date | 1991-05-30 |