The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Digital 3-chip Color Video Camera, Illuminators, Video Components And Accessories.
| Device ID | K972471 |
| 510k Number | K972471 |
| Device Name: | DIGITAL 3-CHIP COLOR VIDEO CAMERA, ILLUMINATORS, VIDEO COMPONENTS AND ACCESSORIES |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | SMITH & NEPHEW, INC. 160 DASCOMB RD. Andover, MA 01810 |
| Contact | Deborah J Connors |
| Correspondent | Deborah J Connors SMITH & NEPHEW, 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 | 1997-07-01 |
| Decision Date | 1997-10-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00885556609705 | K972471 | 000 |
| 03596010442451 | K972471 | 000 |
| 00885554005998 | K972471 | 000 |
| 00885554006605 | K972471 | 000 |
| 00885554008562 | K972471 | 000 |
| 00885556600849 | K972471 | 000 |
| 00885556600931 | K972471 | 000 |
| 00885556602874 | K972471 | 000 |
| 00885556602881 | K972471 | 000 |
| 00885556602904 | K972471 | 000 |
| 00885556608777 | K972471 | 000 |
| 00885556608784 | K972471 | 000 |
| 00885556608791 | K972471 | 000 |
| 00885556608807 | K972471 | 000 |
| 00885556609521 | K972471 | 000 |
| 03596010437112 | K972471 | 000 |