The following data is part of a premarket notification filed by Associated Medical Products Co. with the FDA for Leg Bag Extension Tube.
Device ID | K802606 |
510k Number | K802606 |
Device Name: | LEG BAG EXTENSION TUBE |
Classification | Collector, Urine, (and Accessories) For Indwelling Catheter |
Applicant | ASSOCIATED MEDICAL PRODUCTS CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | KNX |
CFR Regulation Number | 876.5250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1980-10-21 |
Decision Date | 1980-10-31 |