FDA 510(k) Application Details - K203211

Device Classification Name Syringe, Piston

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510(K) Number K203211
Device Name Syringe, Piston
Applicant DLP Medical Products, Corp.
203 S. St. Mary's St., Suite 160
San Antonio, TX 78205 US
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Contact Luis Ernesto De La Puente Paniagua
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Regulation Number 880.5860

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Classification Product Code FMF
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Date Received 10/30/2020
Decision Date 02/09/2023
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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