GLUSEAL 5ML DISPENSER, 1 ML DISPENSER, .2 ML DISPENSER

Bandage, Liquid

GLUSTITCH, INC.

The following data is part of a premarket notification filed by Glustitch, Inc. with the FDA for Gluseal 5ml Dispenser, 1 Ml Dispenser, .2 Ml Dispenser.

Pre-market Notification Details

• Device ID: K030574
• 510k Number: K030574
• Device Name: GLUSEAL 5ML DISPENSER, 1 ML DISPENSER, .2 ML DISPENSER
• Classification: Bandage, Liquid
• Applicant: GLUSTITCH, INC. #307 7188 PROGRESS WAY Delta, B.c., CA V4g 1m6
• Contact: Don Blacklock
• Correspondent: Don Blacklock; GLUSTITCH, INC. #307 7188 PROGRESS WAY Delta, B.c., CA V4g 1m6
• Product Code: KMF
• CFR Regulation Number: 880.5090 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2003-02-24
• Decision Date: 2003-08-21
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
D795210	K030574	000
D795201	K030574	000
D795191	K030574	000
D795183	K030574	000
D795173	K030574	000
D795161	K030574	000
D795151	K030574	000