IONTOPATCH

Device, Iontophoresis, Other Uses

BIRCH POINT MEDICAL, INC.

The following data is part of a premarket notification filed by Birch Point Medical, Inc. with the FDA for Iontopatch.

Pre-market Notification Details

• Device ID: K992708
• 510k Number: K992708
• Device Name: IONTOPATCH
• Classification: Device, Iontophoresis, Other Uses
• Applicant: BIRCH POINT MEDICAL, INC. 2660 PATTON RD. Roseville, MN 55113
• Contact: Walter L Sembrowich
• Correspondent: Walter L Sembrowich; BIRCH POINT MEDICAL, INC. 2660 PATTON RD. Roseville, MN 55113
• Product Code: EGJ
• CFR Regulation Number: 890.5525 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1999-08-11
• Decision Date: 2000-02-01

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
20815611021030	K992708	000
20815611021023	K992708	000
20815611021016	K992708	000
20815611021009	K992708	000
10815611020036	K992708	000
10815611020029	K992708	000
10815611020012	K992708	000
10815611020005	K992708	000