The following data is part of a premarket notification filed by Cp Medical with the FDA for Velcro Fistula Pressure Clamps.
| Device ID | K853536 |
| 510k Number | K853536 |
| Device Name: | VELCRO FISTULA PRESSURE CLAMPS |
| Classification | System Accessories, Extracorporeal |
| Applicant | CP MEDICAL 1775 WHITTIER AVE. Costa Mesa, CA 92627 |
| Contact | Carl Grodach |
| Correspondent | Carl Grodach CP MEDICAL 1775 WHITTIER AVE. Costa Mesa, CA 92627 |
| Product Code | KXM |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-08-23 |
| Decision Date | 1985-10-17 |