Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
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
Predetermined Change
Control Plan Authorized		 No
-
-