The following data is part of a premarket notification filed by Jelco Laboratories with the FDA for Filter, I.v. (#4700).
Device ID | K760110 |
510k Number | K760110 |
Device Name: | FILTER, I.V. (#4700) |
Classification | Set, Administration, Intravascular |
Applicant | JELCO LABORATORIES 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | FPA |
CFR Regulation Number | 880.5440 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1976-06-24 |
Decision Date | 1976-07-16 |