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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K853558
Device Name DOSIMETRIC RELEASE/RADIATION STERILIZ. ABSORB GAUZ
Applicant
American White Cross, Inc.
56 Westcott Rd.
Stamford,  CT  06902
Applicant Contact CORNELIA DAMSKY
Correspondent
American White Cross, Inc.
56 Westcott Rd.
Stamford,  CT  06902
Correspondent Contact CORNELIA DAMSKY
Date Received08/26/1985
Decision Date 09/05/1985
Decision Substantially Equivalent (SESE)
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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