The following data is part of a premarket notification filed by Minntech Corp. with the FDA for Renalin Cold Sterilant.
Device ID | K941439 |
510k Number | K941439 |
Device Name: | RENALIN COLD STERILANT |
Classification | Disinfectant, Medical Devices |
Applicant | MINNTECH CORP. 14905 28TH AVE. N. Minneapolis, MN 55447 |
Contact | Mark W Aldana |
Correspondent | Mark W Aldana MINNTECH CORP. 14905 28TH AVE. N. Minneapolis, MN 55447 |
Product Code | LRJ |
CFR Regulation Number | 880.6890 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-03-24 |
Decision Date | 1995-06-26 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
30677964021825 | K941439 | 000 |
30677964011741 | K941439 | 000 |
30677964011680 | K941439 | 000 |
30677964011628 | K941439 | 000 |
30677964000288 | K941439 | 000 |