TYMPANOSTOMY TUBE

Tube, Tympanostomy

Grace Medical, Inc.

The following data is part of a premarket notification filed by Grace Medical, Inc. with the FDA for Tympanostomy Tube.

Pre-market Notification Details

• Device ID: K943325
• 510k Number: K943325
• Device Name: TYMPANOSTOMY TUBE
• Classification: Tube, Tympanostomy
• Applicant: Grace Medical, Inc. 8624 NORTH LAKE COVE Arlington, TN 38002
• Contact: Anthony D Prescott
• Correspondent: Anthony D Prescott; Grace Medical, Inc. 8624 NORTH LAKE COVE Arlington, TN 38002
• Product Code: ETD
• CFR Regulation Number: 874.3880 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1994-07-11
• Decision Date: 1994-10-11

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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