The following data is part of a premarket notification filed by Midmark Corp. with the FDA for Model #527 Ophthalmic Stretcher.
| Device ID | K904011 |
| 510k Number | K904011 |
| Device Name: | MODEL #527 OPHTHALMIC STRETCHER |
| Classification | Stretcher, Wheeled |
| 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 | FPO |
| CFR Regulation Number | 880.6910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-08-29 |
| Decision Date | 1990-10-03 |