The following data is part of a premarket notification filed by Sharpoint, Inc. with the FDA for Ophthalmic Knife.
| Device ID | K822112 |
| 510k Number | K822112 |
| Device Name: | OPHTHALMIC KNIFE |
| Classification | Knife, Ophthalmic |
| Applicant | SHARPOINT, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | HNN |
| CFR Regulation Number | 886.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-07-19 |
| Decision Date | 1982-08-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10848782029928 | K822112 | 000 |
| 10848782004826 | K822112 | 000 |
| 10848782004833 | K822112 | 000 |
| 10848782004840 | K822112 | 000 |
| 10848782004857 | K822112 | 000 |
| 10848782004864 | K822112 | 000 |
| 10848782004871 | K822112 | 000 |
| 10848782004888 | K822112 | 000 |
| 10848782004895 | K822112 | 000 |
| 10848782004901 | K822112 | 000 |
| 10848782004918 | K822112 | 000 |
| 10848782004925 | K822112 | 000 |
| 10848782004932 | K822112 | 000 |
| 10848782004949 | K822112 | 000 |
| 10848782023520 | K822112 | 000 |
| 10848782023629 | K822112 | 000 |
| 10848782029904 | K822112 | 000 |
| 10848782029911 | K822112 | 000 |
| 10848782004819 | K822112 | 000 |