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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 And Burn, Occlusive
510(k) Number K990079
Device Name FASTSEAL CHEST WOUND DRESSING
Applicant
Greenfield Medical Technologies, Inc.
40 Valentine Rd.
Northborough,  MA  01532
Applicant Contact DONALD R GORSUCH
Correspondent
Greenfield Medical Technologies, Inc.
40 Valentine Rd.
Northborough,  MA  01532
Correspondent Contact DONALD R GORSUCH
Classification Product Code
MGP  
Date Received01/11/1999
Decision Date 12/23/1999
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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