The following data is part of a premarket notification filed by Surgivision, Inc. with the FDA for Mri Neuro Drape.
| Device ID | K091343 |
| 510k Number | K091343 |
| Device Name: | MRI NEURO DRAPE |
| Classification | Drape, Surgical |
| Applicant | SURGIVISION, INC. 11874 SOUTH EVELYN CIRCLE Houston, TX 77071 |
| Contact | J. Harvey Knauss |
| Correspondent | J. Harvey Knauss SURGIVISION, INC. 11874 SOUTH EVELYN CIRCLE Houston, TX 77071 |
| Product Code | KKX |
| CFR Regulation Number | 878.4370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-05-06 |
| Decision Date | 2009-09-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850359007225 | K091343 | 000 |
| 00850359007218 | K091343 | 000 |
| 00850359007201 | K091343 | 000 |
| 00850359007188 | K091343 | 000 |