The following data is part of a premarket notification filed by Smith & Nephew Endoscopy, Inc. with the FDA for Smith & Nephew Mis Instruments.
| Device ID | K970949 |
| 510k Number | K970949 |
| Device Name: | SMITH & NEPHEW MIS INSTRUMENTS |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | SMITH & NEPHEW ENDOSCOPY, INC. 130 FORBES BLVD. Mansfield, MA 02048 |
| Contact | Amy L Walters |
| Correspondent | Amy L Walters SMITH & NEPHEW ENDOSCOPY, INC. 130 FORBES BLVD. Mansfield, MA 02048 |
| Product Code | GCJ |
| Subsequent Product Code | HET |
| Subsequent Product Code | KNS |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-03-14 |
| Decision Date | 1997-04-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00885556607886 | K970949 | 000 |
| 00885556603000 | K970949 | 000 |
| 00885554013375 | K970949 | 000 |
| 00885554011722 | K970949 | 000 |
| 00885554009958 | K970949 | 000 |
| 03596010465214 | K970949 | 000 |
| 03596010430892 | K970949 | 000 |