The following data is part of a premarket notification filed by Jelco Laboratories with the FDA for Filter Tube.
Device ID | K780519 |
510k Number | K780519 |
Device Name: | FILTER TUBE |
Classification | Filter, Conduction, Anesthetic |
Applicant | JELCO LABORATORIES 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | BSN |
CFR Regulation Number | 868.5130 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1978-03-31 |
Decision Date | 1978-05-09 |