The following data is part of a premarket notification filed by Inman Liebelt Corp. with the FDA for Ilc Leg Bag Holder.
Device ID | K903611 |
510k Number | K903611 |
Device Name: | ILC LEG BAG HOLDER |
Classification | Bag, Urine Collection, Leg, For External Use, Sterile |
Applicant | INMAN LIEBELT CORP. P.O.BOX 171077 Arlington, TX 76003 |
Contact | Clay Wilson |
Correspondent | Clay Wilson INMAN LIEBELT CORP. P.O.BOX 171077 Arlington, TX 76003 |
Product Code | FAQ |
CFR Regulation Number | 876.5250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-08-09 |
Decision Date | 1990-10-26 |