The following data is part of a premarket notification filed by Smith & Nephew Dyonics, Inc. with the FDA for Smith & Nephew Dyonics Laparoscopy System.
| Device ID | K914919 |
| 510k Number | K914919 |
| Device Name: | SMITH & NEPHEW DYONICS LAPAROSCOPY SYSTEM |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | SMITH & NEPHEW DYONICS, INC. 160 DASCOMB RD. Andover, MA 01810 |
| Contact | Eric Bannon |
| Correspondent | Eric Bannon SMITH & NEPHEW DYONICS, INC. 160 DASCOMB RD. Andover, MA 01810 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-11-04 |
| Decision Date | 1992-01-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00885556643754 | K914919 | 000 |
| 03596010251107 | K914919 | 000 |
| 03596010113702 | K914919 | 000 |
| 03596010113634 | K914919 | 000 |
| 03596010103352 | K914919 | 000 |
| 03596010103345 | K914919 | 000 |
| 03596010103338 | K914919 | 000 |
| 03596010103321 | K914919 | 000 |
| 03596010103314 | K914919 | 000 |
| 03596010103307 | K914919 | 000 |
| 03596010103291 | K914919 | 000 |
| 03596010373236 | K914919 | 000 |
| 03596010103246 | K914919 | 000 |
| 03596010413963 | K914919 | 000 |
| 03596010430847 | K914919 | 000 |
| 03596010528933 | K914919 | 000 |
| 00885556643747 | K914919 | 000 |
| 00885556643730 | K914919 | 000 |
| 00885556643723 | K914919 | 000 |
| 00885556643716 | K914919 | 000 |
| 00885556643709 | K914919 | 000 |
| 00885556643693 | K914919 | 000 |
| 00885556611340 | K914919 | 000 |
| 00885556608494 | K914919 | 000 |
| 00885556607589 | K914919 | 000 |
| 00885556602591 | K914919 | 000 |
| 00885554010893 | K914919 | 000 |
| 00885554008739 | K914919 | 000 |
| 03596010001566 | K914919 | 000 |