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: K981575
• 510k Number: K981575
• Device Name: TYMPANOSTOMY TUBE
• Classification: Tube, Tympanostomy
• Applicant: Grace Medical, Inc. 7715 HWY. 70, SUITE 109 Bartlett, TN 38133
• Contact: Anthony D Prescott
• Correspondent: Anthony D Prescott; Grace Medical, Inc. 7715 HWY. 70, SUITE 109 Bartlett, TN 38133
• Product Code: ETD
• CFR Regulation Number: 874.3880 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1998-05-04
• Decision Date: 1998-07-15

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00844505003216	K981575	000
00844505003018	K981575	000
00844505002998	K981575	000
00844505002981	K981575	000
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10844505012642	K981575	000
10844505012635	K981575	000
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00844505002875	K981575	000
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00844505002783	K981575	000
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10844505014394	K981575	000
00844505011914	K981575	000
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00844505004282	K981575	000
00844505004275	K981575	000
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00844505003544	K981575	000
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00844505006583	K981575	000
00844505006576	K981575	000
00844505003223	K981575	000