The following data is part of a premarket notification filed by Covidien with the FDA for Premium Surgiclip Iii.
Device ID | K142869 |
510k Number | K142869 |
Device Name: | Premium Surgiclip III |
Classification | Clip, Implantable |
Applicant | COVIDIEN 60 Middletown Avenue North Haven, CT 06473 |
Contact | Michael Koczocik |
Correspondent | Michael Koczocik COVIDIEN 60 Middletown Avenue North Haven, CT 06473 |
Product Code | FZP |
CFR Regulation Number | 878.4300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2014-10-01 |
Decision Date | 2014-10-30 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
20884521517391 | K142869 | 000 |