The following data is part of a premarket notification filed by Interdent, Inc. with the FDA for Non-pressure Autoclave For Sterilization.
Device ID | K823457 |
510k Number | K823457 |
Device Name: | NON-PRESSURE AUTOCLAVE FOR STERILIZATION |
Classification | Sterilizer, Steam |
Applicant | INTERDENT, INC. 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 | 1982-11-18 |
Decision Date | 1983-02-23 |