FDA device listing
HEMIGARD Interlock
FDA device listing 1386435483 · SUTUREGARD Medical, Inc.
Key facts
| Proprietary names | HEMIGARD Interlock |
|---|---|
| Owner/operator | SUTUREGARD Medical, Inc. |
| Owner/operator number | 10058863 |
| Product codes | MKY |
| Device names | MKY - System, Skin Closure |
| Device class | Class I |
| Classification regulations (21 CFR) | 878.4320 |
| Review panels | General & Plastic Surgery |
| Registered establishments | SUTUREGARD MEDICAL, INC. |
| Establishment registrations | 3015045268 |
| FEI numbers | 3015045268 |
| Establishment operations | Specification Developer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None listed Premarket submission listed
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device listings
Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.
Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database