The following data is part of a premarket notification filed by North American Rescue Products, Inc. with the FDA for Junctional Emergency Treatment Tool Model 30-0088.
| Device ID | K123194 |
| 510k Number | K123194 |
| Device Name: | JUNCTIONAL EMERGENCY TREATMENT TOOL MODEL 30-0088 |
| Classification | Clamp, Vascular |
| Applicant | NORTH AMERICAN RESCUE PRODUCTS, INC. 35 TEDWALL COURT Greer, SC 29650 -4791 |
| Contact | William Slevin |
| Correspondent | William Slevin NORTH AMERICAN RESCUE PRODUCTS, INC. 35 TEDWALL COURT Greer, SC 29650 -4791 |
| Product Code | DXC |
| CFR Regulation Number | 870.4450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-10-11 |
| Decision Date | 2013-01-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00842209100002 | K123194 | 000 |