The following data is part of a premarket notification filed by Metrex Research Corp. with the FDA for Metricide 28.
Device ID | K931052 |
510k Number | K931052 |
Device Name: | METRICIDE 28 |
Classification | Sterilant, Medical Devices |
Applicant | METREX RESEARCH CORP. P.O. BOX 646 10270 SOUTH PROGRESS WAY Parker, CO 80134 |
Contact | Vera Buffaloe |
Correspondent | Vera Buffaloe METREX RESEARCH CORP. P.O. BOX 646 10270 SOUTH PROGRESS WAY Parker, CO 80134 |
Product Code | MED |
CFR Regulation Number | 880.6885 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-02-16 |
Decision Date | 1994-12-06 |