The following data is part of a premarket notification filed by Smith & Nephew Richards, Inc. with the FDA for Richard Rod Lens Laryngoscope.
| Device ID | K941264 |
| 510k Number | K941264 |
| Device Name: | RICHARD ROD LENS LARYNGOSCOPE |
| Classification | Bronchoscope (flexible Or Rigid) |
| Applicant | SMITH & NEPHEW RICHARDS, INC. 2925 APPLING RD. Bartlett, TN 38133 |
| Contact | Ronald K Smith |
| Correspondent | Ronald K Smith SMITH & NEPHEW RICHARDS, INC. 2925 APPLING RD. Bartlett, TN 38133 |
| Product Code | EOQ |
| CFR Regulation Number | 874.4680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-03-16 |
| Decision Date | 1994-07-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00821925030756 | K941264 | 000 |