The following data is part of a premarket notification filed by Microvasive with the FDA for Microvasive Silicone Spray.
| Device ID | K854063 |
| 510k Number | K854063 |
| Device Name: | MICROVASIVE SILICONE SPRAY |
| Classification | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories |
| Applicant | MICROVASIVE 31 MAPLE ST. Milford, MA 01757 |
| Contact | Samuel D Wade |
| Correspondent | Samuel D Wade MICROVASIVE 31 MAPLE ST. Milford, MA 01757 |
| Product Code | KCT |
| CFR Regulation Number | 880.6850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-10-04 |
| Decision Date | 1985-10-25 |