PARTIAL OSSICULAR REPLACEMENT PROSTHESES

Prosthesis, Partial Ossicular Replacement

Grace Medical, Inc.

The following data is part of a premarket notification filed by Grace Medical, Inc. with the FDA for Partial Ossicular Replacement Prostheses.

Pre-market Notification Details

• Device ID: K060518
• 510k Number: K060518
• Device Name: PARTIAL OSSICULAR REPLACEMENT PROSTHESES
• Classification: Prosthesis, Partial Ossicular Replacement
• Applicant: Grace Medical, Inc. 8500 WOLF LAKE DR., STE. 110 Memphis, TN 38133
• Contact: Jeff Cobb
• Correspondent: Jeff Cobb; Grace Medical, Inc. 8500 WOLF LAKE DR., STE. 110 Memphis, TN 38133
• Product Code: ETB
• CFR Regulation Number: 874.3450 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2006-02-27
• Decision Date: 2006-06-28
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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