OPTUS SINUSCOPES AND ACCESSORIES

Nasopharyngoscope (flexible Or Rigid)

OPTUS, INC.

The following data is part of a premarket notification filed by Optus, Inc. with the FDA for Optus Sinuscopes And Accessories.

Pre-market Notification Details

• Device ID: K944656
• 510k Number: K944656
• Device Name: OPTUS SINUSCOPES AND ACCESSORIES
• Classification: Nasopharyngoscope (flexible Or Rigid)
• Applicant: OPTUS, INC. 1200 SOUTH PARKER RD. Denver, CO 80231
• Contact: Peter Duffy
• Correspondent: Peter Duffy; OPTUS, INC. 1200 SOUTH PARKER RD. Denver, CO 80231
• Product Code: EOB
• CFR Regulation Number: 874.4760 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1994-09-21
• Decision Date: 1995-01-26

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
04059082029573	K944656	000
04059082029283	K944656	000
04059082029276	K944656	000
04059082029252	K944656	000
04059082029245	K944656	000
04059082014227	K944656	000
04059082007786	K944656	000
04059082007779	K944656	000
04059082006970	K944656	000
04059082006963	K944656	000
04059082006956	K944656	000
04059082029443	K944656	000
04059082029450	K944656	000
04059082029467	K944656	000
04059082029566	K944656	000
04059082029559	K944656	000
04059082029542	K944656	000
04059082029535	K944656	000
04059082029528	K944656	000
04059082029511	K944656	000
04059082029504	K944656	000
04059082029498	K944656	000
04059082029481	K944656	000
04059082029474	K944656	000
04059082006949	K944656	000
04059082006932	K944656	000
04059082006352	K944656	000
04059082002965	K944656	000
04059082002941	K944656	000
04059082002927	K944656	000
04059082002859	K944656	000
04059082002835	K944656	000
04059082002811	K944656	000
M2744407701	K944656	000
M2744407401	K944656	000
M2744407301	K944656	000
M2744407201	K944656	000
04059082003115	K944656	000
04059082003139	K944656	000
04059082003153	K944656	000
04059082006338	K944656	000
04059082006321	K944656	000
04059082006307	K944656	000
04059082003245	K944656	000
04059082003221	K944656	000
04059082003214	K944656	000
04059082003207	K944656	000
04059082003191	K944656	000
04059082003184	K944656	000
04059082003160	K944656	000
M2744407001	K944656	000
04059082029580	K944656	000
04961333240524	K944656	000
04961333230563	K944656	000
04961333230556	K944656	000
04961333230549	K944656	000
04961333230532	K944656	000
04961333230525	K944656	000
04961333230518	K944656	000
04961333230327	K944656	000
04961333230310	K944656	000
04961333230303	K944656	000
04961333230297	K944656	000
04961333230570	K944656	000
04961333230587	K944656	000
04961333231126	K944656	000
04961333240517	K944656	000
04961333232888	K944656	000
04961333232871	K944656	000
04961333232864	K944656	000
04961333232857	K944656	000
04961333232840	K944656	000
04961333232833	K944656	000
04961333232826	K944656	000
04961333232819	K944656	000
04961333231652	K944656	000
04961333230280	K944656	000
04961333230273	K944656	000
04961333230266	K944656	000
04059082029696	K944656	000
04059082029689	K944656	000
04059082029672	K944656	000
04059082029665	K944656	000
04059082029658	K944656	000
04059082029641	K944656	000
04059082029634	K944656	000
04059082029627	K944656	000
04059082029610	K944656	000
04059082029603	K944656	000
04059082029702	K944656	000
04961333230143	K944656	000
04961333230150	K944656	000
04961333230259	K944656	000
04961333230242	K944656	000
04961333230235	K944656	000
04961333230228	K944656	000
04961333230211	K944656	000
04961333230204	K944656	000
04961333230198	K944656	000
04961333230181	K944656	000
04961333230174	K944656	000
04961333230167	K944656	000
04059082029597	K944656	000