FDA 510(k) Application Details - K222925

Device Classification Name Syringe, Piston

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510(K) Number K222925
Device Name Syringe, Piston
Applicant Lifelong Meditech Private Limited
Plot No.18, Sector-5, IMT Manesar
Gurgaon 122050 IN
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Contact Mr. Hamendra Nath Srivastava
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Regulation Number 880.5860

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Classification Product Code FMF
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Date Received 09/26/2022
Decision Date 07/18/2023
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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