HEALY/MONTGOMERY STENT SYSTEM (HMS SYSTEM(TM))

Tube, Tracheal (w/wo Connector)

BOSTON MEDICAL PRODUCTS, INC.

The following data is part of a premarket notification filed by Boston Medical Products, Inc. with the FDA for Healy/montgomery Stent System (hms System(tm)).

Pre-market Notification Details

• Device ID: K912290
• 510k Number: K912290
• Device Name: HEALY/MONTGOMERY STENT SYSTEM (HMS SYSTEM(TM))
• Classification: Tube, Tracheal (w/wo Connector)
• Applicant: BOSTON MEDICAL PRODUCTS, INC. 87 RUMFORD AVE. Waltham, MA 02154
• Contact: Stuart K Montgomery
• Correspondent: Stuart K Montgomery; BOSTON MEDICAL PRODUCTS, INC. 87 RUMFORD AVE. Waltham, MA 02154
• Product Code: BTR
• CFR Regulation Number: 868.5730 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1991-05-23
• Decision Date: 1991-08-26

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
EBES820950	K912290	000
EBES8200110	K912290	000
EBES8200090	K912290	000
EBES8200070	K912290	000