FDA 510(k) Application Details - K221875

Device Classification Name Wrap, Sterilization

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510(K) Number K221875
Device Name Wrap, Sterilization
Applicant Qianjiang Kingphar Medical Packaging & Printing Co., Ltd.
Dongjing Road 23, Yuanlin Office
Qianjiang 433100 CN
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Contact Zhao Fusong
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Regulation Number 880.6850

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Classification Product Code FRG
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Date Received 06/28/2022
Decision Date 02/13/2023
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee OR - Orthopedic
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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