The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Smith & Nephew Dyonics Endoscopes And Accessories.
| Device ID | K980604 |
| 510k Number | K980604 |
| Device Name: | SMITH & NEPHEW DYONICS ENDOSCOPES 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 | 1998-02-17 |
| Decision Date | 1998-05-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00885556611326 | K980604 | 000 |
| 03596010267306 | K980604 | 000 |
| 03596010380654 | K980604 | 000 |
| 03596010380661 | K980604 | 000 |
| 03596010566140 | K980604 | 000 |
| 23596010465966 | K980604 | 000 |
| 03596010567161 | K980604 | 000 |
| 00885556539682 | K980604 | 000 |
| 00885556603420 | K980604 | 000 |
| 00885556603444 | K980604 | 000 |
| 00885556607732 | K980604 | 000 |
| 00885556609057 | K980604 | 000 |
| 00885556609064 | K980604 | 000 |
| 00885556609071 | K980604 | 000 |
| 00885556609484 | K980604 | 000 |
| 00885556611319 | K980604 | 000 |
| 03596010266262 | K980604 | 000 |