The following data is part of a premarket notification filed by Novare Surgical Systems, Inc. with the FDA for Enclose Ii Anastomosis Assist Device.
| Device ID | K032589 |
| 510k Number | K032589 |
| Device Name: | ENCLOSE II ANASTOMOSIS ASSIST DEVICE |
| Classification | Clamp, Vascular |
| Applicant | NOVARE SURGICAL SYSTEMS, INC. 200 GREGORY LN. SUITE C-100 Pleasant Hill, CA 94523 -3389 |
| Contact | David W Schlerf |
| Correspondent | David W Schlerf NOVARE SURGICAL SYSTEMS, INC. 200 GREGORY LN. SUITE C-100 Pleasant Hill, CA 94523 -3389 |
| Product Code | DXC |
| CFR Regulation Number | 870.4450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-08-22 |
| Decision Date | 2003-09-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00852621004208 | K032589 | 000 |
| 00852621004192 | K032589 | 000 |
| 00852621004185 | K032589 | 000 |