The following data is part of a premarket notification filed by Keeler Instruments, Inc. with the FDA for Donaldson Natural Eyepatch 'patient Pak'.
| Device ID | K874411 |
| 510k Number | K874411 |
| Device Name: | DONALDSON NATURAL EYEPATCH 'PATIENT PAK' |
| Classification | Pad, Eye |
| Applicant | KEELER INSTRUMENTS, INC. 456 PKWY. Broomall, PA 19008 |
| Contact | Van Arsdale |
| Correspondent | Van Arsdale KEELER INSTRUMENTS, INC. 456 PKWY. Broomall, PA 19008 |
| Product Code | HMP |
| CFR Regulation Number | 878.4440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-10-28 |
| Decision Date | 1988-01-27 |