The following data is part of a premarket notification filed by Aesculap Instruments Corp. with the FDA for Container System.
Device ID | K792558 |
510k Number | K792558 |
Device Name: | CONTAINER SYSTEM |
Classification | Sterilizer, Steam |
Applicant | AESCULAP INSTRUMENTS CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | FLE |
CFR Regulation Number | 880.6880 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-12-12 |
Decision Date | 1979-12-27 |