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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name nasopharyngoscope (flexible or rigid)
510(k) Number K222587
Device Name PatCom Distal Chip Endoscope
Applicant
H&A Mui Enterprises Inc.
145 Traders Blvd. E., Unit #34
Mississauga,  CA L4Z 3L3
Applicant Contact Tammy Mui
Correspondent
H&A Mui Enterprises Inc.
145 Traders Blvd. E., Unit #34
Mississauga,  CA L4Z 3L3
Correspondent Contact Tammy Mui
Regulation Number874.4760
Classification Product Code
EOB  
Date Received08/26/2022
Decision Date 07/28/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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