PocketDoc™ Micro Wound Therapy System

Negative Pressure Wound Therapy Powered Suction Pump

Pensar Medical, LLC

The following data is part of a premarket notification filed by Pensar Medical, Llc with the FDA for Pocketdoc™ Micro Wound Therapy System.

Pre-market Notification Details

Device IDK200223
510k NumberK200223
Device Name:PocketDoc™ Micro Wound Therapy System
ClassificationNegative Pressure Wound Therapy Powered Suction Pump
Applicant Pensar Medical, LLC 684 Parkridge Avenue Norco,  CA  92860
ContactDavid Buchicchio
CorrespondentPierre Bounaud
AcKnowledge Regulatory Strategies, LLC 2251 San Diego Ave, Suite B-257 San Diego,  CA  92110
Product CodeOMP  
CFR Regulation Number878.4780 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-01-29
Decision Date2020-10-23

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