The following data is part of a premarket notification filed by Davol, Inc. with the FDA for Ellik Evacuator.
Device ID | K791306 |
510k Number | K791306 |
Device Name: | ELLIK EVACUATOR |
Classification | Evacuator, Gastro-urology |
Applicant | DAVOL, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | KQT |
CFR Regulation Number | 876.4370 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-07-16 |
Decision Date | 1979-08-03 |