The following data is part of a premarket notification filed by Spirus Medical, Inc. with the FDA for Spirus Medical Surgical Instrument.
| Device ID | K080042 |
| 510k Number | K080042 |
| Device Name: | SPIRUS MEDICAL SURGICAL INSTRUMENT |
| Classification | Lubricant, Patient |
| Applicant | SPIRUS MEDICAL, INC. 5 WHITCOMB AVENUE Ayer, MA 01432 |
| Contact | Pamela Papineau |
| Correspondent | Pamela Papineau SPIRUS MEDICAL, INC. 5 WHITCOMB AVENUE Ayer, MA 01432 |
| Product Code | KMJ |
| CFR Regulation Number | 880.6375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-01-08 |
| Decision Date | 2008-04-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00867630000233 | K080042 | 000 |