The following data is part of a premarket notification filed by Smith & Nephew Dyonics, Inc. with the FDA for Smith & Nephew Dyonics Inc. Electronic Endoscope.
| Device ID | K936071 |
| 510k Number | K936071 |
| Device Name: | SMITH & NEPHEW DYONICS INC. ELECTRONIC ENDOSCOPE |
| Classification | Laparoscope, Gynecologic (and Accessories) |
| Applicant | SMITH & NEPHEW DYONICS, INC. 4533 ENTERPRISE DR. Oklahoma City, OK 73128 |
| Contact | Steven L Jackson |
| Correspondent | Steven L Jackson SMITH & NEPHEW DYONICS, INC. 4533 ENTERPRISE DR. Oklahoma City, OK 73128 |
| Product Code | HET |
| CFR Regulation Number | 884.1720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-12-20 |
| Decision Date | 1994-08-19 |