The following data is part of a premarket notification filed by Concept, Inc. with the FDA for Viterous Suction Cutter.
Device ID | K761353 |
510k Number | K761353 |
Device Name: | VITEROUS SUCTION CUTTER |
Classification | Instrument, Vitreous Aspiration And Cutting, Battery-powered |
Applicant | CONCEPT, 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 | 1976-12-28 |
Decision Date | 1977-01-05 |