The following data is part of a premarket notification filed by Absentee Shawnee Bandage Group with the FDA for Shawnee Products Kit I.
Device ID | K921762 |
510k Number | K921762 |
Device Name: | SHAWNEE PRODUCTS KIT I |
Classification | First Aid Kit With Drug |
Applicant | ABSENTEE SHAWNEE BANDAGE GROUP 1201 HOLLY LN. Tecumseh, OK 74873 |
Contact | Earl Little |
Correspondent | Earl Little ABSENTEE SHAWNEE BANDAGE GROUP 1201 HOLLY LN. Tecumseh, OK 74873 |
Product Code | LRR |
CFR Regulation Number | 510(k) Premarket Notification [🔎] |
Decision | Substantially Equivalent - Kit With Drugs (SEKD) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-04-14 |
Decision Date | 1993-01-06 |