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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 K000901
Device Name KLINIDRAPE SURGICAL GOWNS, NON-REINFORCED, BASIC PROTECTIONS AND STANDARD PROTECTION
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 07/05/2000
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
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