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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 K000902
Device Name KLINIDRAPE REINFORCED SURGICAL GOWNS
Applicant
Molnlycke Health Care, Inc.
500 Baldwin Tower
Eddystone,  PA  19022
Applicant Contact MIGUEL A NEGRON
Correspondent
Molnlycke Health Care, Inc.
500 Baldwin Tower
Eddystone,  PA  19022
Correspondent Contact MIGUEL A NEGRON
Regulation Number878.4040
Classification Product Code
FYA  
Date Received03/21/2000
Decision Date 07/11/2000
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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