The following data is part of a premarket notification filed by Aesculap, Ltd. with the FDA for Sterilcontainer System.
Device ID | K112671 |
510k Number | K112671 |
Device Name: | STERILCONTAINER SYSTEM |
Classification | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories |
Applicant | AESCULAP, LTD. 3773 Corporate Parkway Center Valley, PA 18034 |
Contact | Denise Adams |
Correspondent | Denise Adams AESCULAP, LTD. 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 | 2011-09-14 |
Decision Date | 2012-05-04 |
Summary: | summary |