MICROCON 800M, MICROCON 400M, MICROCON EXC, MICROCON EX, MICROCON WALLMAP

Cleaner, Air, Medical Recirculating

BIOLOGICAL CONTROLS, INC.

The following data is part of a premarket notification filed by Biological Controls, Inc. with the FDA for Microcon 800m, Microcon 400m, Microcon Exc, Microcon Ex, Microcon Wallmap.

Pre-market Notification Details

• Device ID: K974682
• 510k Number: K974682
• Device Name: MICROCON 800M, MICROCON 400M, MICROCON EXC, MICROCON EX, MICROCON WALLMAP
• Classification: Cleaner, Air, Medical Recirculating
• Applicant: BIOLOGICAL CONTROLS, INC. ONE INDUSTRIAL WAY WEST BUILDING E, UNIT M Eatontown, NJ 07724
• Contact: Gary D Messina
• Correspondent: Gary D Messina; BIOLOGICAL CONTROLS, INC. ONE INDUSTRIAL WAY WEST BUILDING E, UNIT M Eatontown, NJ 07724
• Product Code: FRF
• CFR Regulation Number: 880.5045 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1997-12-15
• Decision Date: 1998-01-23

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00811095020183	K974682	000
00811095020176	K974682	000
00811095020169	K974682	000
00811095020152	K974682	000
00811095020138	K974682	000
00811095020084	K974682	000
00811095020077	K974682	000
00811095020022	K974682	000
00811095020015	K974682	000