The following data is part of a premarket notification filed by Sam Medical Products with the FDA for Sam Junctional Tourniquet.
Device ID | K123694 |
510k Number | K123694 |
Device Name: | SAM JUNCTIONAL TOURNIQUET |
Classification | Clamp, Vascular |
Applicant | SAM MEDICAL PRODUCTS 27350 SW 95th Ave Ste 3038 Bldg 30 Wilsonville, OR 97070 |
Contact | Jack N Mccutcheon |
Correspondent | Jack N Mccutcheon SAM MEDICAL PRODUCTS 27350 SW 95th Ave Ste 3038 Bldg 30 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 | 2012-12-03 |
Decision Date | 2013-03-07 |
Summary: | summary |