The following data is part of a premarket notification filed by Aesculap, Inc. with the FDA for Aesculap Sterilcontainer S.
Device ID | K093493 |
510k Number | K093493 |
Device Name: | AESCULAP STERILCONTAINER S |
Classification | Wrap, Sterilization |
Applicant | AESCULAP, INC. 3773 Corporate Parkway Center Valley, PA 18034 |
Contact | Kathy Racosky |
Correspondent | Kathy Racosky AESCULAP, INC. 3773 Corporate Parkway Center Valley, PA 18034 |
Product Code | FRG |
CFR Regulation Number | 880.6850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2009-11-10 |
Decision Date | 2010-07-27 |
Summary: | summary |