AED HYSTEROSCOPE AND ACCESSORIES

Hysteroscope (and Accessories)

NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.

The following data is part of a premarket notification filed by National Advanced Endoscopy Devices, Inc. with the FDA for Aed Hysteroscope And Accessories.

Pre-market Notification Details

• Device ID: K141515
• 510k Number: K141515
• Device Name: AED HYSTEROSCOPE AND ACCESSORIES
• Classification: Hysteroscope (and Accessories)
• Applicant: NATIONAL ADVANCED ENDOSCOPY DEVICES, INC. 22134 SHERMAN WAY Canoga Park, CA 91303
• Contact: Gayle Butler
• Correspondent: Gayle Butler; NATIONAL ADVANCED ENDOSCOPY DEVICES, INC. 22134 SHERMAN WAY Canoga Park, CA 91303
• Product Code: HIH
• CFR Regulation Number: 884.1690 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2014-06-09
• Decision Date: 2015-01-07
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00848657011709	K141515	000
00848657067508	K141515	000
00848657087674	K141515	000
00848657087490	K141515	000
00848657087483	K141515	000
00848657087476	K141515	000
00848657087469	K141515	000
00848657087452	K141515	000
00848657086844	K141515	000
00848657086837	K141515	000
00848657085120	K141515	000
00848657085489	K141515	000
00848657011693	K141515	000
00848657011242	K141515	000
00848657011235	K141515	000
00848657011228	K141515	000
00848657011211	K141515	000
00848657087735	K141515	000
00848657087346	K141515	000
00848657087131	K141515	000
00848657085496	K141515	000
00848657086820	K141515	000
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00848657074872	K141515	000
00848657074858	K141515	000
00848657074834	K141515	000
00848657074810	K141515	000
00848657076685	K141515	000
00848657076678	K141515	000
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00848657074926	K141515	000
00848657075091	K141515	000
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00848657086707	K141515	000
00848657085427	K141515	000
00848657084796	K141515	000
00848657084482	K141515	000
00848657076241	K141515	000
00848657019088	K141515	000
00848657075978	K141515	000
00848657075138	K141515	000
00848657076296	K141515	000
00848657011716	K141515	000
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00848657066488	K141515	000
00848657066471	K141515	000
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00848657066457	K141515	000
00848657066440	K141515	000
00848657066433	K141515	000
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00848657016223	K141515	000
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00848657016278	K141515	000
00848657016230	K141515	000
00848657013680	K141515	000