SILICONE TYMPANOSTOMY TUBES

Tube, Tympanostomy

SMITH & NEPHEW RICHARDS, INC.

The following data is part of a premarket notification filed by Smith & Nephew Richards, Inc. with the FDA for Silicone Tympanostomy Tubes.

Pre-market Notification Details

• Device ID: K932166
• 510k Number: K932166
• Device Name: SILICONE TYMPANOSTOMY TUBES
• Classification: Tube, Tympanostomy
• Applicant: SMITH & NEPHEW RICHARDS, INC. 2925 APPLING RD. Bartlett, TN 38133
• Contact: Jeff Cobb
• Correspondent: Jeff Cobb; SMITH & NEPHEW RICHARDS, INC. 2925 APPLING RD. 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: 1993-05-04
• Decision Date: 1993-07-26

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00821925026124	K932166	000
00821925019614	K932166	000
00821925019768	K932166	000
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