The following data is part of a premarket notification filed by Catco Medical, Inc. with the FDA for Catco Urological Catheter.
Device ID | K944782 |
510k Number | K944782 |
Device Name: | CATCO UROLOGICAL CATHETER |
Classification | Catheter, Straight |
Applicant | CATCO MEDICAL, INC. 9010 FOXLAND DR. San Antonio, TX 78230 |
Contact | Clyde N Baker |
Correspondent | Clyde N Baker CATCO MEDICAL, INC. 9010 FOXLAND DR. San Antonio, TX 78230 |
Product Code | EZD |
CFR Regulation Number | 876.5130 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-09-27 |
Decision Date | 1994-10-13 |