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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mask, Surgical
510(k) Number K030239
Device Name MEGATECH SCIENTIFIC FACE MASK
Applicant
MEGATECH SCIENTIFIC PTE LTD
BLK 2 BUKIT BATOK STREET 24
SKYTECH #09-03,  SG 659480
Applicant Contact CHIAM KIA CHEE
Correspondent
MEGATECH SCIENTIFIC PTE LTD
BLK 2 BUKIT BATOK STREET 24
SKYTECH #09-03,  SG 659480
Correspondent Contact CHIAM KIA CHEE
Regulation Number878.4040
Classification Product Code
FXX  
Date Received01/23/2003
Decision Date 07/24/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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