The following data is part of a premarket notification filed by Forge Medical Inc. with the FDA for Vasostat Hemostasis Device.
Device ID | K123041 |
510k Number | K123041 |
Device Name: | VASOSTAT HEMOSTASIS DEVICE |
Classification | Clamp, Vascular |
Applicant | FORGE MEDICAL INC. 150 LEVINBERG LANE Wayne, NJ 07470 |
Contact | Mason Diamond |
Correspondent | Mason Diamond FORGE MEDICAL INC. 150 LEVINBERG LANE Wayne, NJ 07470 |
Product Code | DXC |
CFR Regulation Number | 870.4450 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2012-09-28 |
Decision Date | 2013-05-29 |
Summary: | summary |