The following data is part of a premarket notification filed by Instrumed, Inc. with the FDA for Disposable Color-cuffs.
| Device ID | K890014 |
| 510k Number | K890014 |
| Device Name: | DISPOSABLE COLOR-CUFFS |
| Classification | Tourniquet, Pneumatic |
| Applicant | INSTRUMED, INC. 12911 NE 126TH PL. Kirkland, WA 98034 |
| Contact | Jerry L Spence |
| Correspondent | Jerry L Spence INSTRUMED, INC. 12911 NE 126TH PL. Kirkland, WA 98034 |
| Product Code | KCY |
| CFR Regulation Number | 878.5910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-01-03 |
| Decision Date | 1989-01-24 |