The following data is part of a premarket notification filed by Snyder Laboratories, Inc. with the FDA for Foley Catheterization Tray.
Device ID | K790254 |
510k Number | K790254 |
Device Name: | FOLEY CATHETERIZATION TRAY |
Classification | Tray, Catheterization, Sterile Urethral, With Or Without Catheter (kit) |
Applicant | SNYDER LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | FCM |
CFR Regulation Number | 876.5130 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-02-06 |
Decision Date | 1979-04-10 |