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 IDK141515
510k NumberK141515
Device Name:AED HYSTEROSCOPE AND ACCESSORIES
ClassificationHysteroscope (and Accessories)
Applicant NATIONAL ADVANCED ENDOSCOPY DEVICES, INC. 22134 SHERMAN WAY Canoga Park,  CA  91303
ContactGayle Butler
CorrespondentGayle Butler
NATIONAL ADVANCED ENDOSCOPY DEVICES, INC. 22134 SHERMAN WAY Canoga Park,  CA  91303
Product CodeHIH  
CFR Regulation Number884.1690 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-06-09
Decision Date2015-01-07
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00848657011242 K141515 000
00848657087483 K141515 000
00848657087476 K141515 000
00848657087469 K141515 000
00848657087452 K141515 000
00848657086844 K141515 000
00848657086837 K141515 000
00848657086820 K141515 000
00848657086813 K141515 000
00848657086714 K141515 000
00848657087490 K141515 000
00848657087674 K141515 000
00848657067508 K141515 000
00848657011235 K141515 000
00848657011228 K141515 000
00848657011211 K141515 000
00848657087735 K141515 000
00848657087346 K141515 000
00848657087131 K141515 000
00848657085496 K141515 000
00848657085489 K141515 000
00848657085120 K141515 000
00848657086707 K141515 000
00848657085427 K141515 000
00848657074810 K141515 000
00848657076685 K141515 000
00848657076678 K141515 000
00848657076319 K141515 000
00848657076302 K141515 000
00848657076296 K141515 000
00848657076821 K141515 000
00848657076814 K141515 000
00848657076807 K141515 000
00848657074834 K141515 000
00848657074858 K141515 000
00848657074872 K141515 000
00848657084796 K141515 000
00848657084482 K141515 000
00848657076241 K141515 000
00848657019088 K141515 000
00848657075978 K141515 000
00848657075138 K141515 000
00848657075091 K141515 000
00848657074926 K141515 000
00848657074919 K141515 000
00848657076791 K141515 000
00848657011693 K141515 000
00848657085953 K141515 000
00848657066396 K141515 000
00848657066365 K141515 000
00848657022071 K141515 000
00848657022064 K141515 000
00848657021272 K141515 000
00848657021258 K141515 000
00848657019767 K141515 000
00848657019750 K141515 000
00848657019743 K141515 000
00848657066402 K141515 000
00848657066419 K141515 000
00848657066426 K141515 000
00848657085946 K141515 000
00848657085939 K141515 000
00848657085922 K141515 000
00848657066488 K141515 000
00848657066471 K141515 000
00848657066464 K141515 000
00848657066457 K141515 000
00848657066440 K141515 000
00848657066433 K141515 000
00848657019736 K141515 000
00848657019729 K141515 000
00848657014663 K141515 000
00848657014052 K141515 000
00848657014045 K141515 000
00848657013949 K141515 000
00848657013833 K141515 000
00848657013826 K141515 000
00848657013697 K141515 000
00848657013680 K141515 000
00848657011716 K141515 000
00848657015929 K141515 000
00848657016162 K141515 000
00848657016179 K141515 000
00848657019712 K141515 000
00848657019705 K141515 000
00848657019699 K141515 000
00848657019682 K141515 000
00848657016810 K141515 000
00848657016599 K141515 000
00848657016278 K141515 000
00848657016230 K141515 000
00848657016223 K141515 000
00848657011709 K141515 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.