The following data is part of a premarket notification filed by Aesculap, Inc. with the FDA for Reusable Sterilcontainer Filter Model #jk090.
| Device ID | K041623 |
| 510k Number | K041623 |
| Device Name: | REUSABLE STERILCONTAINER FILTER MODEL #JK090 |
| Classification | Wrap, Sterilization |
| Applicant | AESCULAP, INC. 3773 Corporate Parkway Center Valley, PA 18034 |
| Contact | Matthew M Hull |
| Correspondent | Matthew M Hull 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 | 2004-06-16 |
| Decision Date | 2004-12-13 |
| Summary: | summary |