The following data is part of a premarket notification filed by Varian Assoc., Inc. with the FDA for Clinitex Vis-x Aspirating Accessory.
Device ID | K780852 |
510k Number | K780852 |
Device Name: | CLINITEX VIS-X ASPIRATING ACCESSORY |
Classification | Instrument, Vitreous Aspiration And Cutting, Battery-powered |
Applicant | VARIAN ASSOC., INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | HKP |
CFR Regulation Number | 886.4150 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1978-05-22 |
Decision Date | 1978-11-03 |