The following data is part of a premarket notification filed by Site Microsurgical Systems, Inc. with the FDA for .2mm, .4mm, .5mm Irrigation And Aspiration Hand..
| Device ID | K883926 |
| 510k Number | K883926 |
| Device Name: | .2MM, .4MM, .5MM IRRIGATION AND ASPIRATION HAND. |
| Classification | Instrument, Vitreous Aspiration And Cutting, Ac-powered |
| Applicant | SITE MICROSURGICAL SYSTEMS, INC. 135 GIBRALTAR RD. Horsham, PA 19044 |
| Contact | James K Mccracken |
| Correspondent | James K Mccracken SITE MICROSURGICAL SYSTEMS, INC. 135 GIBRALTAR RD. Horsham, PA 19044 |
| Product Code | HQE |
| CFR Regulation Number | 886.4150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-09-15 |
| Decision Date | 1988-11-15 |