The following data is part of a premarket notification filed by S. Percy Amoils with the FDA for Amoils Epithelial Scrubber.
| Device ID | K962989 |
| 510k Number | K962989 |
| Device Name: | AMOILS EPITHELIAL SCRUBBER |
| Classification | Burr, Corneal, Battery-powered |
| Applicant | S. PERCY AMOILS 333 WEST WACKER DR. SUITE 2600 Chicago, IL 60606 |
| Contact | Richard O Wood, Esq. |
| Correspondent | Richard O Wood, Esq. S. PERCY AMOILS 333 WEST WACKER DR. SUITE 2600 Chicago, IL 60606 |
| Product Code | HOG |
| CFR Regulation Number | 886.4070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-08-01 |
| Decision Date | 1997-01-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00628693343053 | K962989 | 000 |
| 00628693343046 | K962989 | 000 |
| 00628693343039 | K962989 | 000 |
| 00628693343107 | K962989 | 000 |
| 00628693343091 | K962989 | 000 |
| 00628693343268 | K962989 | 000 |
| 00628693343251 | K962989 | 000 |
| 00628693343244 | K962989 | 000 |
| 00628693343237 | K962989 | 000 |