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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cap, Surgical
510(k) Number K870617
Device Name VARIOUS TYES OF SURGICAL GARMENTS
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
FYF  
Date Received02/12/1987
Decision Date 03/09/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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