The following data is part of a premarket notification filed by Covidien with the FDA for Signia Four-bay Smart Charger (to Be Used With Signia Stapler).
Device ID | K170348 |
510k Number | K170348 |
Device Name: | Signia Four-Bay Smart Charger (to Be Used With Signia Stapler) |
Classification | Staple, Implantable |
Applicant | Covidien 60 Middletown Avenue North Haven, CT 06473 |
Contact | Katherine Y. Choi |
Correspondent | Katherine Y. Choi Covidien 60 Middletown Avenue North Haven, CT 06473 |
Product Code | GDW |
CFR Regulation Number | 878.4750 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-02-03 |
Decision Date | 2017-03-02 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
10884521543850 | K170348 | 000 |