The following data is part of a premarket notification filed by Absentee Shawnee Bandage Group with the FDA for Shawnee Product Kit Iv.
Device ID | K923319 |
510k Number | K923319 |
Device Name: | SHAWNEE PRODUCT KIT IV |
Classification | Tape And Bandage, Adhesive |
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 | KGX |
CFR Regulation Number | 880.5240 [🔎] |
Decision | Substantially Equivalent - Kit With Drugs (SEKD) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-07-07 |
Decision Date | 1993-06-17 |