CLEAR-GUARD MIDI, CLEAR-GUARD MIDI W/FLEXTUBE, CLEAR-THERM MINI, CLEAR-THERM MINI W/FLEXTUBE, MODELS 1644,1644-T,1831,18

Filter, Bacterial, Breathing-circuit

INTERSURGICAL, INC.

The following data is part of a premarket notification filed by Intersurgical, Inc. with the FDA for Clear-guard Midi, Clear-guard Midi W/flextube, Clear-therm Mini, Clear-therm Mini W/flextube, Models 1644,1644-t,1831,18.

Pre-market Notification Details

• Device ID: K983610
• 510k Number: K983610
• Device Name: CLEAR-GUARD MIDI, CLEAR-GUARD MIDI W/FLEXTUBE, CLEAR-THERM MINI, CLEAR-THERM MINI W/FLEXTUBE, MODELS 1644,1644-T,1831,18
• Classification: Filter, Bacterial, Breathing-circuit
• Applicant: INTERSURGICAL, INC. 417 ELECTRONICS PKWY. Liverpool, NY 13088
• Contact: Thomas R Gunerman
• Correspondent: Thomas R Gunerman; 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: 1998-10-14
• Decision Date: 1999-04-30

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
05030267026623	K983610	000
05030267026616	K983610	000