The following data is part of a premarket notification filed by Covidien with the FDA for Bluntport Blunt Trocar With Threaded Anchor 5mm-12mm.
Device ID | K142547 |
510k Number | K142547 |
Device Name: | Bluntport Blunt Trocar With Threaded Anchor 5mm-12mm |
Classification | Laparoscope, General & Plastic Surgery |
Applicant | COVIDIEN 60 MIDDLETOWN AVE. North Haven, CT 06473 |
Contact | Mary Mellows |
Correspondent | Mary Mellows COVIDIEN 60 MIDDLETOWN AVE. North Haven, CT 06473 |
Product Code | GCJ |
CFR Regulation Number | 876.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2014-09-10 |
Decision Date | 2014-12-09 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
30884521621057 | K142547 | 000 |
20884521515700 | K142547 | 000 |