The following data is part of a premarket notification filed by Sybron Corp. with the FDA for Ritter Sterilizer.
Device ID | K801309 |
510k Number | K801309 |
Device Name: | RITTER STERILIZER |
Classification | Sterilizer, Steam |
Applicant | SYBRON CORP. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | FLE |
CFR Regulation Number | 880.6880 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1980-06-03 |
Decision Date | 1980-06-20 |