The following data is part of a premarket notification filed by Volcano Corporation with the FDA for Sterile Equipment Covers.
| Device ID | K052395 |
| 510k Number | K052395 |
| Device Name: | STERILE EQUIPMENT COVERS |
| Classification | Drape, Surgical |
| Applicant | VOLCANO CORPORATION 2870 KILGORE RD. Rancho Cordova, CA 95670 |
| Contact | Michelle J Badal |
| Correspondent | Michelle J Badal VOLCANO CORPORATION 2870 KILGORE RD. Rancho Cordova, CA 95670 |
| Product Code | KKX |
| CFR Regulation Number | 878.4370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-08-31 |
| Decision Date | 2005-12-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10845225012707 | K052395 | 000 |
| 20845225012698 | K052395 | 000 |
| 20845225012681 | K052395 | 000 |