The following data is part of a premarket notification filed by Site Microsurgical Systems, Inc. with the FDA for 180 Tip, 1/a Handpiece .3mm End Opening For Opht..
| Device ID | K920582 |
| 510k Number | K920582 |
| Device Name: | 180 TIP, 1/A HANDPIECE .3MM END OPENING FOR OPHT. |
| Classification | Instrument, Vitreous Aspiration And Cutting, Ac-powered |
| Applicant | SITE MICROSURGICAL SYSTEMS, INC. 135 GIBRALTAR RD. Horsham, PA 19044 |
| Contact | Gay Brunt-miller |
| Correspondent | Gay Brunt-miller 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 | 1992-02-10 |
| Decision Date | 1992-05-08 |