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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, Antimicrobial
510(k) Number K922918
Device Name BARRIER SAF-TE HYDROGEL DRAPE
Applicant
Johnson & Johnson International
P.O. Box 90130
2500 Arbrook Blvd.
Arlington,  TX  76004
Applicant Contact T. M WENDT
Correspondent
Johnson & Johnson International
P.O. Box 90130
2500 Arbrook Blvd.
Arlington,  TX  76004
Correspondent Contact T. M WENDT
Regulation Number878.4370
Classification Product Code
KKX  
Date Received06/18/1992
Decision Date 07/06/1993
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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