The following data is part of a premarket notification filed by Covidien with the FDA for Autosuture Protack; Tacker System; Absorbatack Fixation Devices.
Device ID | K090470 |
510k Number | K090470 |
Device Name: | AUTOSUTURE PROTACK; TACKER SYSTEM; ABSORBATACK FIXATION DEVICES |
Classification | Endoscopic Tissue Approximation Device |
Applicant | COVIDIEN 60 MIDDLETWON DR North Haven, CT 06473 |
Contact | Jennifer Brennan |
Correspondent | Jennifer Brennan COVIDIEN 60 MIDDLETWON DR North Haven, CT 06473 |
Product Code | OCW |
CFR Regulation Number | 876.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2009-02-23 |
Decision Date | 2009-05-14 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
20884521070452 | K090470 | 000 |
10884521070479 | K090470 | 000 |
20884521070506 | K090470 | 000 |
20884521070490 | K090470 | 000 |
20884521070483 | K090470 | 000 |
20884521070407 | K090470 | 000 |