The following data is part of a premarket notification filed by Novare Surgical Systems, Inc. with the FDA for Flexline Clamp.
| Device ID | K010727 |
| 510k Number | K010727 |
| Device Name: | FLEXLINE CLAMP |
| 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-03-12 |
| Decision Date | 2002-08-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00857987006248 | K010727 | 000 |
| 00850001784955 | K010727 | 000 |
| 00850001784962 | K010727 | 000 |
| 00852621004215 | K010727 | 000 |
| 00852621004222 | K010727 | 000 |
| 00852621004239 | K010727 | 000 |
| 00852621004246 | K010727 | 000 |
| 00852621004253 | K010727 | 000 |
| 00852621004260 | K010727 | 000 |
| 00852621004277 | K010727 | 000 |
| 00852621004284 | K010727 | 000 |
| 00852621004291 | K010727 | 000 |
| 00852621004307 | K010727 | 000 |
| 00857987006200 | K010727 | 000 |
| 00857987006217 | K010727 | 000 |
| 00857987006224 | K010727 | 000 |
| 00857987006231 | K010727 | 000 |
| 00850001784948 | K010727 | 000 |