FILTER

Filter, Bacterial, Breathing-circuit

PROMEDIC, INC.

The following data is part of a premarket notification filed by Promedic, Inc. with the FDA for Filter.

Pre-market Notification Details

• Device ID: K970102
• 510k Number: K970102
• Device Name: FILTER
• Classification: Filter, Bacterial, Breathing-circuit
• Applicant: PROMEDIC, INC. 6329 WEST WATERVIEW CT. Mccordsville, IN 46055 -9501
• Contact: Paul E Dryden
• Correspondent: Paul E Dryden; PROMEDIC, INC. 6329 WEST WATERVIEW CT. Mccordsville, IN 46055 -9501
• Product Code: CAH
• CFR Regulation Number: 868.5260 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1997-01-13
• Decision Date: 1997-06-24
• Summary: summary