ISO-GARD FILTER ANGLED(18212)/ISO-GARD FILTER STRAIGHT(19212)

Filter, Bacterial, Breathing-circuit

GIBECK, INC.

The following data is part of a premarket notification filed by Gibeck, Inc. with the FDA for Iso-gard Filter Angled(18212)/iso-gard Filter Straight(19212).

Pre-market Notification Details

• Device ID: K965016
• 510k Number: K965016
• Device Name: ISO-GARD FILTER ANGLED(18212)/ISO-GARD FILTER STRAIGHT(19212)
• Classification: Filter, Bacterial, Breathing-circuit
• Applicant: GIBECK, INC. 10640 EAST 59TH ST. P.O. BOX 36430 Indianapolis, IN 46236
• Contact: Bill Briley
• Correspondent: Bill Briley; GIBECK, INC. 10640 EAST 59TH ST. P.O. BOX 36430 Indianapolis, IN 46236
• Product Code: CAH
• CFR Regulation Number: 868.5260 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1996-12-16
• Decision Date: 1997-12-02
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
24026704348002	K965016	000
34026704927723	K965016	000