The following data is part of a premarket notification filed by Kit Pak, Inc. with the FDA for Skin Scrub Kit.
Device ID | K890570 |
510k Number | K890570 |
Device Name: | SKIN SCRUB KIT |
Classification | General Surgery Tray |
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 | LRO |
CFR Regulation Number | 878.4370 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-02-06 |
Decision Date | 1989-05-05 |