The following data is part of a premarket notification filed by Site Microsurgical Systems, Inc. with the FDA for Site Solution Administration Set.
| Device ID | K874725 |
| 510k Number | K874725 |
| Device Name: | SITE SOLUTION ADMINISTRATION SET |
| Classification | Set, Administration, Intravascular |
| 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 | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-11-18 |
| Decision Date | 1988-04-01 |