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 |