The following data is part of a premarket notification filed by Medical Ingenuities with the FDA for Patent Hemostasis Band (ph Band).
| Device ID | K201695 |
| 510k Number | K201695 |
| Device Name: | Patent Hemostasis Band (PH Band) |
| Classification | Clamp, Vascular |
| Applicant | Medical Ingenuities 345 Browning Court Wheaton, IL 60189 |
| Contact | Richard "chip" Corrigan |
| Correspondent | Valerie Defiesta-ng Experien Group, LLC 224 Airport Parkway, Suite 250 San Jose, CA 95110 |
| Product Code | DXC |
| CFR Regulation Number | 870.4450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-06-22 |
| Decision Date | 2020-10-30 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860006401702 | K201695 | 000 |