The following data is part of a premarket notification filed by 3m Company with the FDA for Precise Ila And Ilan Surgical Staples.
Device ID | K885222 |
510k Number | K885222 |
Device Name: | PRECISE ILA AND ILAN SURGICAL STAPLES |
Classification | Staple, Implantable |
Applicant | 3M COMPANY CHEMOLITE BLVD. & WASHINGTON CITY RD. 19 Cottae Grove, MN 55016 |
Contact | Charles W Opp |
Correspondent | Charles W Opp 3M COMPANY CHEMOLITE BLVD. & WASHINGTON CITY RD. 19 Cottae Grove, MN 55016 |
Product Code | GDW |
CFR Regulation Number | 878.4750 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-12-20 |
Decision Date | 1989-02-03 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
20884521063188 | K885222 | 000 |
20884521063171 | K885222 | 000 |
20884521063164 | K885222 | 000 |
10884521064607 | K885222 | 000 |
10884521064614 | K885222 | 000 |