The following data is part of a premarket notification filed by Kit Pak, Inc. with the FDA for Kit Pak Dressing Change Tray.
Device ID | K941499 |
510k Number | K941499 |
Device Name: | KIT PAK DRESSING CHANGE TRAY |
Classification | Tape And Bandage, Adhesive |
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 | KGX |
CFR Regulation Number | 880.5240 [🔎] |
Decision | Substantially Equivalent - Kit With Drugs (SEKD) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-03-29 |
Decision Date | 1994-07-20 |