Roosin Xeroform Petrolatum Dressing

Dressing, Wound, Drug

Roosin Medical Co., Ltd

The following data is part of a premarket notification filed by Roosin Medical Co., Ltd with the FDA for Roosin Xeroform Petrolatum Dressing.

Pre-market Notification Details

Device IDK181478
510k NumberK181478
Device Name:Roosin Xeroform Petrolatum Dressing
ClassificationDressing, Wound, Drug
Applicant Roosin Medical Co., Ltd 8 Yuandong Road, KouAn Town, Gaogang Taizhou,  CN 225321
ContactCharles Shen
CorrespondentCharles Shen
Manton Business And Technology Services LLC 37 Winding Ridge Oakland,  NJ  07436
Product CodeFRO  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductYes
Date Received2018-06-05
Decision Date2019-09-13
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
26958868747002 K181478 000
10810113578092 K181478 000
10810113578108 K181478 000
10810113578115 K181478 000
26958868747040 K181478 000
26958868747057 K181478 000
26958868747064 K181478 000
26958868747071 K181478 000
26958868747019 K181478 000
10810113578085 K181478 000

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