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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Drape, Surgical
510(k) Number K122000
Device Name HM SURGICAL DRAPES HM SURGICAL EQUIPMENT COVER
Applicant
Changzhou Holymed Products Co., Ltd.
528 Changwu Rd. S.
Wujin District
Changhou,  CN 213167
Applicant Contact ALAN YU
Correspondent
Changzhou Holymed Products Co., Ltd.
528 Changwu Rd. S.
Wujin District
Changhou,  CN 213167
Correspondent Contact ALAN YU
Regulation Number878.4370
Classification Product Code
KKX  
Date Received07/09/2012
Decision Date 12/12/2012
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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