The following data is part of a premarket notification filed by Fischer Surgical Inc. with the FDA for Nci Spatula.
| Device ID | K110734 |
| 510k Number | K110734 |
| Device Name: | NCI SPATULA |
| Classification | Graft Insertion Instrument For Endothelial Keratoplasty |
| Applicant | FISCHER SURGICAL INC. 1012 PALMER LANE, SUITE 200 Imperial, MO 63052 |
| Contact | Jessica Dixon |
| Correspondent | Jessica Dixon FISCHER SURGICAL INC. 1012 PALMER LANE, SUITE 200 Imperial, MO 63052 |
| Product Code | OTZ |
| CFR Regulation Number | 886.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-03-16 |
| Decision Date | 2012-05-31 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860010356203 | K110734 | 000 |