The following data is part of a premarket notification filed by Kit Pak, Inc. with the FDA for Kit Pak Urinary Care Supplies.
Device ID | K925281 |
510k Number | K925281 |
Device Name: | KIT PAK URINARY CARE SUPPLIES |
Classification | Accessories, Catheter, G-u |
Applicant | KIT PAK, INC. 825 CHASE AVE. Elk Grove Village, IL 60007 |
Contact | Thomas J Sanders |
Correspondent | Thomas J Sanders KIT PAK, INC. 825 CHASE AVE. Elk Grove Village, IL 60007 |
Product Code | KNY |
CFR Regulation Number | 876.5130 [🔎] |
Decision | Substantially Equivalent - Kit (SESK) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-10-20 |
Decision Date | 1993-04-19 |