The following data is part of a premarket notification filed by Aesculap, Inc. with the FDA for Sterilcontainer S.
Device ID | K143729 |
510k Number | K143729 |
Device Name: | SterilContainer S |
Classification | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories |
Applicant | AESCULAP, INC. 3773 CORPORATE PARKWAY Center Valley, PA 18034 |
Contact | Denise R Adams |
Correspondent | Denise R Adams AESCULAP, INC. 3773 CORPORATE PARKWAY Center Valley, PA 18034 |
Product Code | KCT |
CFR Regulation Number | 880.6850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2014-12-29 |
Decision Date | 2015-08-18 |
Summary: | summary |