The following data is part of a premarket notification filed by K2 Medical Gmbh & Co. Kg with the FDA for K2 Medical Vascular Clamps.
Device ID | K120492 |
510k Number | K120492 |
Device Name: | K2 MEDICAL VASCULAR CLAMPS |
Classification | Clamp, Vascular |
Applicant | K2 MEDICAL GMBH & CO. KG UNTER BUCHSTEIG 3A Tuttlingen, DE 78532 |
Contact | Peter Fetzer |
Correspondent | Peter Fetzer K2 MEDICAL GMBH & CO. KG UNTER BUCHSTEIG 3A Tuttlingen, DE 78532 |
Product Code | DXC |
CFR Regulation Number | 870.4450 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2012-02-17 |
Decision Date | 2012-04-30 |
Summary: | summary |