The following data is part of a premarket notification filed by Instrumed, Inc. with the FDA for Clean-cuff.
| Device ID | K952038 |
| 510k Number | K952038 |
| Device Name: | CLEAN-CUFF |
| Classification | Tourniquet, Pneumatic |
| Applicant | INSTRUMED, INC. 11818 N. CREEK PARKWAY NORTH SUITE 105 Bothell, WA 98011 |
| Contact | Jerry L Spence |
| Correspondent | Jerry L Spence INSTRUMED, INC. 11818 N. CREEK PARKWAY NORTH SUITE 105 Bothell, WA 98011 |
| Product Code | KCY |
| CFR Regulation Number | 878.5910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-05-01 |
| Decision Date | 1995-07-11 |