The following data is part of a premarket notification filed by Serim Research Corp. with the FDA for Wavicide Monitor Strips.
Device ID | K932047 |
510k Number | K932047 |
Device Name: | WAVICIDE MONITOR STRIPS |
Classification | Sterilant, Medical Devices |
Applicant | SERIM RESEARCH CORP. P.O. BOX 4002 Elkhart, IN 46514 -0002 |
Contact | Michael Mckenna |
Correspondent | Michael Mckenna SERIM RESEARCH CORP. P.O. BOX 4002 Elkhart, IN 46514 -0002 |
Product Code | MED |
CFR Regulation Number | 880.6885 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-04-27 |
Decision Date | 1994-06-02 |