The following data is part of a premarket notification filed by Surgical Instruments Belgium Sa with the FDA for Sibel Sa Vascular Clamp.
Device ID | K072834 |
510k Number | K072834 |
Device Name: | SIBEL SA VASCULAR CLAMP |
Classification | Clamp, Vascular |
Applicant | SURGICAL INSTRUMENTS BELGIUM SA 220 RIVER RD. Claremont, NH 03743 -5647 |
Contact | William F Greenrose |
Correspondent | William F Greenrose SURGICAL INSTRUMENTS BELGIUM SA 220 RIVER RD. Claremont, NH 03743 -5647 |
Product Code | DXC |
CFR Regulation Number | 870.4450 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2007-10-03 |
Decision Date | 2008-01-09 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00192896091139 | K072834 | 000 |
00192896090972 | K072834 | 000 |
B09926001940 | K072834 | 000 |