The following data is part of a premarket notification filed by Minntech Corp. with the FDA for Peract 20 Liquid Sterilant.
Device ID | K960513 |
510k Number | K960513 |
Device Name: | PERACT 20 LIQUID STERILANT |
Classification | Sterilant, Medical Devices |
Applicant | MINNTECH CORP. 14605 28TH AVE. NORTH Minneapolis, MN 55447 |
Contact | Leroy J Fischbach |
Correspondent | Leroy J Fischbach MINNTECH CORP. 14605 28TH AVE. NORTH Minneapolis, MN 55447 |
Product Code | MED |
CFR Regulation Number | 880.6885 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-02-05 |
Decision Date | 1997-10-01 |
Summary: | summary |