The following data is part of a premarket notification filed by Aesculap, Inc. with the FDA for Sterilcontainer With Primeline Pro Lid.
Device ID | K172850 |
510k Number | K172850 |
Device Name: | SterilContainer With PrimeLine Pro Lid |
Classification | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories |
Applicant | Aesculap, Inc. 3773 Corporate Parkway Center Valley, PA 18034 |
Contact | Lisa Boyle |
Correspondent | Lisa Boyle Aesculap, Inc. 3773 Corporate Parkway Center Valley, PA 18034 |
Product Code | KCT |
CFR Regulation Number | 880.6850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-09-20 |
Decision Date | 2017-11-17 |
Summary: | summary |