OPTUS HYSTEROSCOPES AND CONTACT HYSTEROSCOPES

Hysteroscope (and Accessories)

OPTUS, INC.

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

Pre-market Notification Details

• Device ID: K945265
• 510k Number: K945265
• Device Name: OPTUS HYSTEROSCOPES AND CONTACT HYSTEROSCOPES
• Classification: Hysteroscope (and Accessories)
• 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: HIH
• CFR Regulation Number: 884.1690 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1994-10-28
• Decision Date: 1995-09-12

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
04059082003757	K945265	000
04059082006451	K945265	000
04059082006475	K945265	000
04059082006505	K945265	000
04059082006529	K945265	000
04059082006536	K945265	000
04059082007670	K945265	000
04059082007694	K945265	000
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04059082007717	K945265	000
04059082007724	K945265	000
04059082007731	K945265	000
04059082012841	K945265	000
04059082006444	K945265	000
04059082006437	K945265	000
04059082006420	K945265	000
04059082003764	K945265	000
04059082003795	K945265	000
04059082003818	K945265	000
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04059082003870	K945265	000
04059082003894	K945265	000
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04059082006055	K945265	000
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04059082006079	K945265	000
04059082006086	K945265	000
04059082012858	K945265	000
04059082012889	K945265	000
04059082013190	K945265	000
04059082032566	K945265	000
04059082032573	K945265	000
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04059082032603	K945265	000
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04059082032627	K945265	000
04059082032634	K945265	000
04059082032641	K945265	000
04059082032658	K945265	000
04059082032665	K945265	000
04059082032672	K945265	000
04059082032559	K945265	000
04059082032542	K945265	000
04059082032535	K945265	000
04059082032412	K945265	000
04059082032429	K945265	000
04059082032436	K945265	000
04059082032443	K945265	000
04059082032450	K945265	000
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04059082032474	K945265	000
04059082032481	K945265	000
04059082032498	K945265	000
04059082032504	K945265	000
04059082032511	K945265	000
04059082032528	K945265	000
04059082032689	K945265	000