DISPOSABLE HAND HELD NEBULIZER

Nebulizer (direct Patient Interface)

INTEC MEDICAL, INC.

The following data is part of a premarket notification filed by Intec Medical, Inc. with the FDA for Disposable Hand Held Nebulizer.

Pre-market Notification Details

• Device ID: K800562
• 510k Number: K800562
• Device Name: DISPOSABLE HAND HELD NEBULIZER
• Classification: Nebulizer (direct Patient Interface)
• Applicant: INTEC MEDICAL, INC. 22200 E. 40 HWY Blue Springs, MO 64015
• Contact: J.w. Brown
• Correspondent: J.w. Brown; INTEC MEDICAL, INC. 22200 E. 40 HWY Blue Springs, MO 64015
• Product Code: CAF
• CFR Regulation Number: 868.5630 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1980-03-12
• Decision Date: 1980-03-25

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
30840330700420	K800562	000
20888277420653	K800562	000
20888277420660	K800562	000
20888277420677	K800562	000
10888277420649	K800562	000
10709078007788	K800562	000
00812574025729	K800562	000
00812574025743	K800562	000
00812574025767	K800562	000
00812574025781	K800562	000
00812574026788	K800562	000
00812574026795	K800562	000
10709078014410	K800562	000
10709078014403	K800562	000
10709078014397	K800562	000
30840330700437	K800562	000
30840330700444	K800562	000
30840330700451	K800562	000
30840330700468	K800562	000
30840330700475	K800562	000
30840330700482	K800562	000
20193489016373	K800562	000
10709078014106	K800562	000
10709078014366	K800562	000
10709078014373	K800562	000
10709078014380	K800562	000
00812574026801	K800562	000
10709078000390	K800562	000
10709078001601	K800562	000
10709078001618	K800562	000
10709078001687	K800562	000
10709078001953	K800562	000
00709078001963	K800562	000
10709078001977	K800562	000
10709078004602	K800562	000
10709078004954	K800562	000
10709078004961	K800562	000
10709078005173	K800562	000
00709078005442	K800562	000
10709078001595	K800562	000
00709078001581	K800562	000
00709078001574	K800562	000
10709078000406	K800562	000
10709078000413	K800562	000
10709078000420	K800562	000
10709078000437	K800562	000
10709078000444	K800562	000
10709078000451	K800562	000
10709078000468	K800562	000
10709078000475	K800562	000
10709078000482	K800562	000
10709078000499	K800562	000
00709078000676	K800562	000
10709078006194	K800562	000