The following data is part of a premarket notification filed by Site Microsurgical Systems, Inc. with the FDA for Modified Site Peristaltic Footswitch.
| Device ID | K905620 |
| 510k Number | K905620 |
| Device Name: | MODIFIED SITE PERISTALTIC FOOTSWITCH |
| Classification | Controller, Foot, Handpiece And Cord |
| Applicant | SITE MICROSURGICAL SYSTEMS, INC. 135 GIBRALTAR RD. Horsham, PA 19044 |
| Contact | Brunt Miller |
| Correspondent | Brunt Miller SITE MICROSURGICAL SYSTEMS, INC. 135 GIBRALTAR RD. Horsham, PA 19044 |
| Product Code | EBW |
| CFR Regulation Number | 872.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-12-14 |
| Decision Date | 1991-02-27 |