The following data is part of a premarket notification filed by Novare Surgical Systems, Inc. with the FDA for Engage Jaw Inserts.
| Device ID | K992980 |
| 510k Number | K992980 |
| Device Name: | ENGAGE JAW INSERTS |
| Classification | Clamp, Vascular |
| Applicant | NOVARE SURGICAL SYSTEMS, INC. 10231 BUBB RD. Cupertino, CA 95014 |
| Contact | Noel Messenger |
| Correspondent | Noel Messenger NOVARE SURGICAL SYSTEMS, INC. 10231 BUBB RD. Cupertino, CA 95014 |
| Product Code | DXC |
| CFR Regulation Number | 870.4450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-09-03 |
| Decision Date | 2000-06-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00852621004901 | K992980 | 000 |
| 00852621004161 | K992980 | 000 |
| 00852621004154 | K992980 | 000 |
| 00852621004147 | K992980 | 000 |
| 00852621004130 | K992980 | 000 |
| 00852621004123 | K992980 | 000 |
| 00852621004116 | K992980 | 000 |
| 00852621004109 | K992980 | 000 |
| 00852621004093 | K992980 | 000 |
| 00852621004086 | K992980 | 000 |
| 00852621004079 | K992980 | 000 |
| 00852621004062 | K992980 | 000 |
| 00852621004055 | K992980 | 000 |
| 00852621004178 | K992980 | 000 |
| 00852621004772 | K992980 | 000 |
| 00852621004895 | K992980 | 000 |
| 00852621004888 | K992980 | 000 |
| 00852621004871 | K992980 | 000 |
| 00852621004864 | K992980 | 000 |
| 00852621004857 | K992980 | 000 |
| 00852621004840 | K992980 | 000 |
| 00852621004833 | K992980 | 000 |
| 00852621004826 | K992980 | 000 |
| 00852621004819 | K992980 | 000 |
| 00852621004802 | K992980 | 000 |
| 00852621004796 | K992980 | 000 |
| 00852621004789 | K992980 | 000 |
| 00852621004000 | K992980 | 000 |