The following data is part of a premarket notification filed by Aspen Laboratories, Inc. with the FDA for Banana Cuff.
| Device ID | K841558 |
| 510k Number | K841558 |
| Device Name: | BANANA CUFF |
| Classification | Tourniquet, Pneumatic |
| Applicant | ASPEN LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KCY |
| CFR Regulation Number | 878.5910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-04-16 |
| Decision Date | 1984-07-16 |