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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Gown, Surgical
510(k) Number K012186
Device Name MASTER & FRANK SURGICAL GOWNS (STERILE)
Applicant
Master & Frank Ent. Co., Ltd.
3892 S. America W. Trl.
Flagstaff,  AZ  86001
Applicant Contact JENNIFER REICH
Correspondent
Master & Frank Ent. Co., Ltd.
3892 S. America W. Trl.
Flagstaff,  AZ  86001
Correspondent Contact JENNIFER REICH
Regulation Number878.4040
Classification Product Code
FYA  
Date Received07/12/2001
Decision Date 12/07/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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