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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 K883828
Device Name CONE MASKS, VARIOUS TYPES OF SURGICAL CONE MASKS
Applicant
GREENE INTERNATIONAL CORP.
P.O. BOX:56-26
TAIPEI, TAIWAN
(FORMOSA) R.O.C.,  TW
Applicant Contact MARY E GREENE
Correspondent
GREENE INTERNATIONAL CORP.
P.O. BOX:56-26
TAIPEI, TAIWAN
(FORMOSA) R.O.C.,  TW
Correspondent Contact MARY E GREENE
Regulation Number878.4040
Classification Product Code
FXX  
Date Received09/09/1988
Decision Date 10/03/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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