The following data is part of a premarket notification filed by Instrumed International, Inc. with the FDA for Instrumed Vascular Clamps.
Device ID | K092544 |
510k Number | K092544 |
Device Name: | INSTRUMED VASCULAR CLAMPS |
Classification | Clamp, Vascular |
Applicant | INSTRUMED INTERNATIONAL, INC. 626 COOPER COURT Schaumburg, IL 60173 |
Contact | Michael Massong |
Correspondent | Michael Massong INSTRUMED INTERNATIONAL, INC. 626 COOPER COURT Schaumburg, IL 60173 |
Product Code | DXC |
CFR Regulation Number | 870.4450 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2009-08-19 |
Decision Date | 2009-10-26 |
Summary: | summary |