MULTIPLE (APEX LOCATOR), MODEL RCM-7

Locator, Root Apex

J. MORITA USA, INC.

The following data is part of a premarket notification filed by J. Morita Usa, Inc. with the FDA for Multiple (apex Locator), Model Rcm-7.

Pre-market Notification Details

• Device ID: K090925
• 510k Number: K090925
• Device Name: MULTIPLE (APEX LOCATOR), MODEL RCM-7
• Classification: Locator, Root Apex
• Applicant: J. MORITA USA, INC. 1425 K STREET NW SUITE 1100 Washington, DC 20005
• Contact: Keith A Barritt
• Correspondent: Keith A Barritt; J. MORITA USA, INC. 1425 K STREET NW SUITE 1100 Washington, DC 20005
• Product Code: LQY
• CFR Regulation Number: 510(k) Premarket Notification [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2009-04-02
• Decision Date: 2009-11-23
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00887919769118	K090925	000