The following data is part of a premarket notification filed by Sam Medical Products with the FDA for Sam Junctional Tourniquet.
| Device ID | K131561 |
| 510k Number | K131561 |
| Device Name: | SAM JUNCTIONAL TOURNIQUET |
| Classification | Clamp, Vascular |
| Applicant | SAM MEDICAL PRODUCTS 27350 SW 95TH AVE STE 3038 Wilsonville, OR 97070 |
| Contact | Jack N Mccutcheon |
| Correspondent | Jack N Mccutcheon SAM MEDICAL PRODUCTS 27350 SW 95TH AVE STE 3038 Wilsonville, OR 97070 |
| Product Code | DXC |
| CFR Regulation Number | 870.4450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-05-30 |
| Decision Date | 2013-07-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10822045000152 | K131561 | 000 |
| 10822045000343 | K131561 | 000 |
| 10822045000350 | K131561 | 000 |
| 10822045000367 | K131561 | 000 |
| 00822045000056 | K131561 | 000 |
| 00822045000063 | K131561 | 000 |
| 00822045000070 | K131561 | 000 |
| 00822045000087 | K131561 | 000 |
| 00822045000094 | K131561 | 000 |
| 00822045000100 | K131561 | 000 |
| 00822045000117 | K131561 | 000 |
| 00822045000124 | K131561 | 000 |
| 10822045000145 | K131561 | 000 |
| 10822045000398 | K131561 | 000 |