The following data is part of a premarket notification filed by Jedmed Instrument Co. with the FDA for Jedmed Laryngeal Scope.
| Device ID | K950925 |
| 510k Number | K950925 |
| Device Name: | JEDMED LARYNGEAL SCOPE |
| Classification | Bronchoscope (flexible Or Rigid) |
| Applicant | JEDMED INSTRUMENT CO. 6096 LEMAY FERRY RD. St.louis, MO 63129 -2217 |
| Contact | Craig R Parks |
| Correspondent | Craig R Parks JEDMED INSTRUMENT CO. 6096 LEMAY FERRY RD. St.louis, MO 63129 -2217 |
| Product Code | EOQ |
| CFR Regulation Number | 874.4680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-03-01 |
| Decision Date | 1995-08-11 |