The following data is part of a premarket notification filed by United Surgical Corp. with the FDA for Systems Plus.
| Device ID | K860014 |
| 510k Number | K860014 |
| Device Name: | SYSTEMS PLUS |
| Classification | Instrument, Vitreous Aspiration And Cutting, Ac-powered |
| Applicant | UNITED SURGICAL CORP. 15500-A ROCKFIELD BLVD. Irvine, CA 92718 |
| Contact | Terry F Herbeck |
| Correspondent | Terry F Herbeck UNITED SURGICAL CORP. 15500-A ROCKFIELD BLVD. Irvine, CA 92718 |
| Product Code | HQE |
| CFR Regulation Number | 886.4150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-01-03 |
| Decision Date | 1986-03-05 |