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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, Occlusive
510(k) Number K885325
Device Name FRASTEC CONFORMANT DRESSING, VARIOUS SIZES
Applicant
Frastec Wound Care Products, Inc.
3830 Boston Rd.
Bronx,  NY  10475
Applicant Contact A MALIA
Correspondent
Frastec Wound Care Products, Inc.
3830 Boston Rd.
Bronx,  NY  10475
Correspondent Contact A MALIA
Regulation Number878.4020
Classification Product Code
NAD  
Date Received12/28/1988
Decision Date 04/17/1989
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
Regulation Medical Specialty General & Plastic Surgery
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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