The following data is part of a premarket notification filed by Inman Liebelt Corp. with the FDA for Ureteral Catheter Holder.
Device ID | K912146 |
510k Number | K912146 |
Device Name: | URETERAL CATHETER HOLDER |
Classification | Accessories, Catheter, G-u |
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 | KNY |
CFR Regulation Number | 876.5130 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-05-15 |
Decision Date | 1991-07-26 |