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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Gown, Isolation, Surgical
510(k) Number K910410
Device Name SURGICAL GOWNS, EXTRA-LARGE SIZE
Applicant
Dawn of Hope Development Center
1500 E. Millard St.
Johnson City,  TN  37601
Applicant Contact JON CARDWELL
Correspondent
Dawn of Hope Development Center
1500 E. Millard St.
Johnson City,  TN  37601
Correspondent Contact JON CARDWELL
Regulation Number878.4040
Classification Product Code
FYC  
Date Received01/29/1991
Decision Date 04/25/1991
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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