Surgical Mask (Procedure Mask) (Models: OH02-01, OH02-01 (Bandage))

Mask, Surgical

Ningbo Ouhan Medical Device Co., Ltd.

The following data is part of a premarket notification filed by Ningbo Ouhan Medical Device Co., Ltd. with the FDA for Surgical Mask (procedure Mask) (models: Oh02-01, Oh02-01 (bandage)).

Pre-market Notification Details

Device IDK203418
510k NumberK203418
Device Name:Surgical Mask (Procedure Mask) (Models: OH02-01, OH02-01 (Bandage))
ClassificationMask, Surgical
Applicant Ningbo Ouhan Medical Device Co., Ltd. No.16, West Ruhu Road, Simen Town Yuyao City,  CN 315470
ContactAnnie Annie
CorrespondentRafi Wong
Pacific Fortune Management Inc. 2350 Mission College BLVD, STE 475 Santa Clara,  CA  95054
Product CodeFXX  
CFR Regulation Number878.4040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-11-19
Decision Date2021-09-17

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