The following data is part of a premarket notification filed by Lemaitre Vascular, Inc. with the FDA for Mollring Multitasc.
Device ID | K121415 |
510k Number | K121415 |
Device Name: | MOLLRING MULTITASC |
Classification | Stripper, Artery, Intraluminal |
Applicant | LEMAITRE VASCULAR, INC. 63 2ND AVENUE Bedford, MA 01803 |
Contact | Andrew Hodgkinson |
Correspondent | Andrew Hodgkinson LEMAITRE VASCULAR, INC. 63 2ND AVENUE Bedford, MA 01803 |
Product Code | DWX |
CFR Regulation Number | 870.4875 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2012-05-11 |
Decision Date | 2012-09-05 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00840663105908 | K121415 | 000 |
00840663105892 | K121415 | 000 |
00840663105885 | K121415 | 000 |
00840663105878 | K121415 | 000 |
00840663105861 | K121415 | 000 |
00840663105854 | K121415 | 000 |
00840663105847 | K121415 | 000 |
00840663105830 | K121415 | 000 |
00840663105823 | K121415 | 000 |