The following data is part of a premarket notification filed by Surgidev Corp. with the FDA for Karickhoff Flying Corpuscle Viewer.
| Device ID | K831829 |
| 510k Number | K831829 |
| Device Name: | KARICKHOFF FLYING CORPUSCLE VIEWER |
| Classification | Maxwell Spot, Ac-powered |
| Applicant | SURGIDEV CORP. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | HIX |
| CFR Regulation Number | 886.1435 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-06-07 |
| Decision Date | 1983-10-19 |