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
00848657011242	K141515	000
00848657087483	K141515	000
00848657087476	K141515	000
00848657087469	K141515	000
00848657087452	K141515	000
00848657086844	K141515	000
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00848657011235	K141515	000
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00848657011211	K141515	000
00848657087735	K141515	000
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00848657087131	K141515	000
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00848657084482	K141515	000
00848657076241	K141515	000
00848657019088	K141515	000
00848657075978	K141515	000
00848657075138	K141515	000
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00848657011709	K141515	000