FLUOROPLASTIC VENTILATION TUBES

Tube, Tympanostomy

GYRUS ENT L.L.C.

The following data is part of a premarket notification filed by Gyrus Ent L.l.c. with the FDA for Fluoroplastic Ventilation Tubes.

Pre-market Notification Details

• Device ID: K992222
• 510k Number: K992222
• Device Name: FLUOROPLASTIC VENTILATION TUBES
• Classification: Tube, Tympanostomy
• Applicant: GYRUS ENT L.L.C. 2925 APPLING RD. Bartlett, TN 38133
• Contact: Alicia E Farage
• Correspondent: Alicia E Farage; GYRUS ENT L.L.C. 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: 1999-07-01
• Decision Date: 1999-08-26
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00821925019850	K992222	000
00821925021624	K992222	000
00821925019010	K992222	000
00821925019027	K992222	000
00821925015111	K992222	000
00821925039742	K992222	000
00821925018099	K992222	000
00821925035027	K992222	000
00821925014862	K992222	000
00821925014879	K992222	000
00821925019256	K992222	000
00821925019843	K992222	000
00821925019881	K992222	000
00821925019683	K992222	000
00821925019690	K992222	000
00821925014848	K992222	000
00821925014169	K992222	000
00821925039681	K992222	000
00821925017962	K992222	000
00821925021006	K992222	000
00821925019829	K992222	000
00821925040953	K992222	000
00821925017979	K992222	000
00821925014855	K992222	000
00821925019294	K992222	000
00821925019867	K992222	000
00821925020108	K992222	000
00821925019706	K992222	000
00821925018129	K992222	000
00821925016101	K992222	000
00821925016118	K992222	000
00821925018112	K992222	000
00821925025011	K992222	000
00821925032675	K992222	000
00821925024786	K992222	000
80821925032794	K992222	000
00821925015142	K992222	000
00821925015821	K992222	000
00821925019737	K992222	000
00821925015159	K992222	000
00821925015135	K992222	000
00821925015708	K992222	000
00821925020658	K992222	000
00821925020634	K992222	000
00821925020580	K992222	000
00821925020603	K992222	000
00821925020641	K992222	000
00821925033979	K992222	000
00821925020368	K992222	000
00821925020351	K992222	000
00821925020665	K992222	000
00821925020375	K992222	000
00821925022676	K992222	000
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00821925020078	K992222	000
00821925033542	K992222	000
00821925018013	K992222	000
00821925019058	K992222	000
00821925015166	K992222	000
00821925019065	K992222	000
00821925013971	K992222	000
00821925015203	K992222	000
00821925019287	K992222	000
00821925014817	K992222	000
00821925015197	K992222	000
00821925015180	K992222	000
00821925014800	K992222	000
00821925019270	K992222	000
00821925019263	K992222	000
00821925018006	K992222	000
00821925015173	K992222	000
00821925039841	K992222	000