HYDRO-GUARD MINI BREATHING FILTER AND HEAT AND MOISTURE EXCHANGER AND AIR-GUARD CLEAR BREATHING FILTER

Filter, Bacterial, Breathing-circuit

INTERSURGICAL, INC.

The following data is part of a premarket notification filed by Intersurgical, Inc. with the FDA for Hydro-guard Mini Breathing Filter And Heat And Moisture Exchanger And Air-guard Clear Breathing Filter.

Pre-market Notification Details

• Device ID: K092409
• 510k Number: K092409
• Device Name: HYDRO-GUARD MINI BREATHING FILTER AND HEAT AND MOISTURE EXCHANGER AND AIR-GUARD CLEAR BREATHING FILTER
• Classification: Filter, Bacterial, Breathing-circuit
• Applicant: INTERSURGICAL, INC. 417 ELECTRONICS PKWY. Liverpool, NY 13088
• Contact: Michael Zalewski
• Correspondent: Michael Zalewski; INTERSURGICAL, INC. 417 ELECTRONICS PKWY. Liverpool, NY 13088
• Product Code: CAH
• CFR Regulation Number: 868.5260 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2009-08-06
• Decision Date: 2010-03-10

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
05030267094493	K092409	000
05030267094479	K092409	000