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510(k) K222587

PatCom Distal Chip Endoscope by H&A Mui Enterprises, Inc. — Product Code EOB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 28, 2023
Date Received
August 26, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Nasopharyngoscope (Flexible Or Rigid)
Device Class
Class II
Regulation Number
874.4760
Review Panel
EN
Submission Type

If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).

Other clearances by H&A Mui Enterprises, Inc.

  • K192691 — PatCom Single-Use Introducer (February 21, 2020)

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