The following data is part of a premarket notification filed by Absentee Shawnee Bandage Group with the FDA for Shawnee Products Kit Ii.
| Device ID | K921761 |
| 510k Number | K921761 |
| Device Name: | SHAWNEE PRODUCTS KIT II |
| Classification | Tape And Bandage, Adhesive |
| Applicant | ABSENTEE SHAWNEE BANDAGE GROUP P.O. BOX 369 1201 HOLLY LANE Tecumseh, OH 74873 |
| Contact | Earl Little |
| Correspondent | Earl Little ABSENTEE SHAWNEE BANDAGE GROUP P.O. BOX 369 1201 HOLLY LANE Tecumseh, OH 74873 |
| Product Code | KGX |
| CFR Regulation Number | 880.5240 [🔎] |
| Decision | Substantially Equivalent - With Drug (SESD) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-04-14 |
| Decision Date | 1993-03-18 |