The following data is part of a premarket notification filed by Combat Medical Systems, Llc with the FDA for Combat Ready Clamp.
Device ID | K102025 |
510k Number | K102025 |
Device Name: | COMBAT READY CLAMP |
Classification | Clamp, Vascular |
Applicant | COMBAT MEDICAL SYSTEMS, LLC 13417 QUIVAS ST Westminster, CO 80234 |
Contact | Calley Herzog |
Correspondent | Calley Herzog COMBAT MEDICAL SYSTEMS, LLC 13417 QUIVAS ST Westminster, CO 80234 |
Product Code | DXC |
CFR Regulation Number | 870.4450 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2010-07-19 |
Decision Date | 2010-08-11 |
Summary: | summary |