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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Gown, Surgical
510(k) Number K894284
Device Name GOWN, OPERATING, SURGICAL
Applicant
Miroz Industries Co.
299 Green Valley Rd.
Staten Island,  NY  10312
Applicant Contact ROSENTHAL
Correspondent
Miroz Industries Co.
299 Green Valley Rd.
Staten Island,  NY  10312
Correspondent Contact ROSENTHAL
Regulation Number878.4040
Classification Product Code
FYA  
Date Received06/23/1989
Decision Date 07/14/1989
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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