The following data is part of a premarket notification filed by Surgi-quip Inc.u with the FDA for Self-contained Mobile Ophthal. Oper. ..
| Device ID | K822427 |
| 510k Number | K822427 |
| Device Name: | SELF-CONTAINED MOBILE OPHTHAL. OPER. . |
| Classification | Table, Operating-room, Manual |
| Applicant | SURGI-QUIP INC.U 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FSE |
| CFR Regulation Number | 878.4950 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-08-12 |
| Decision Date | 1982-09-14 |