INTER-THERM PEDIATRIC HMEF, INTERN-THERM MINI PEDIATRIC ANGLED HMEF

Filter, Bacterial, Breathing-circuit

INTERSURGICAL INCORPORATED

The following data is part of a premarket notification filed by Intersurgical Incorporated with the FDA for Inter-therm Pediatric Hmef, Intern-therm Mini Pediatric Angled Hmef.

Pre-market Notification Details

• Device ID: K141087
• 510k Number: K141087
• Device Name: INTER-THERM PEDIATRIC HMEF, INTERN-THERM MINI PEDIATRIC ANGLED HMEF
• Classification: Filter, Bacterial, Breathing-circuit
• Applicant: INTERSURGICAL INCORPORATED 417 ELECTRONICS PARKWAY Liverpool, NY 13088
• Contact: Michael Zalewski
• Correspondent: Michael Zalewski; INTERSURGICAL INCORPORATED 417 ELECTRONICS PARKWAY 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: 2014-04-28
• Decision Date: 2015-02-12
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
05030267139286	K141087	000
05030267109494	K141087	000