The following data is part of a premarket notification filed by Midmark Corp. with the FDA for #491 Power Otolaryngoly Ch/#498 Proced Ctr & Acces.
| Device ID | K910781 |
| 510k Number | K910781 |
| Device Name: | #491 POWER OTOLARYNGOLY CH/#498 PROCED CTR & ACCES |
| Classification | Unit, Examining/treatment, Ent |
| Applicant | MIDMARK CORP. 60 VISTA DR. P.O. BOX 286 Versailles, OH 45380 |
| Contact | John Oldiges |
| Correspondent | John Oldiges MIDMARK CORP. 60 VISTA DR. P.O. BOX 286 Versailles, OH 45380 |
| Product Code | ETF |
| CFR Regulation Number | 874.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-02-25 |
| Decision Date | 1991-05-15 |