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 |