510(k) Premarket Notification

• Device Classification Name: sterilant, medical devices
• 510(k) Number: K930284
• Device Name: METRICIDE
• Applicant: METREX RESEARCH CORP.; P.O. BOX 646; 10270 SOUTH PROGRESS WAY; PARKER, CO 80134
• Applicant Contact: VERA BUFFALOE
• Correspondent: METREX RESEARCH CORP.; P.O. BOX 646; 10270 SOUTH PROGRESS WAY; PARKER, CO 80134
• Correspondent Contact: VERA BUFFALOE
• Regulation Number: 880.6885
• Classification Product Code: MED
• Date Received: 01/19/1993
• Decision Date: 12/06/1994
• Decision: Substantially Equivalent (SESE)
• Regulation Medical Specialty: General Hospital
• 510k Review Panel: General Hospital
• Type: Traditional
• Reviewed by Third Party: No
• Combination Product: No
• Recalls: CDRH Recalls