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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dressing, Wound, Drug
510(k) Number K864841
Device Name WATER-JEL(R) BURN DRESSING
Applicant
Trilling Resources, Ltd.
250 E. Hartsdale Ave.
Hartsdale,  NY  10530
Applicant Contact CARY S TRILLING
Correspondent
Trilling Resources, Ltd.
250 E. Hartsdale Ave.
Hartsdale,  NY  10530
Correspondent Contact CARY S TRILLING
Classification Product Code
FRO  
Date Received12/09/1986
Decision Date 01/22/1988
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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