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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Accessory, Surgical Apparel
510(k) Number K901221
Device Name PHYSICIAN BARRIER GLOVE, SURGICAL
Applicant
Dynamic Marketing Ent.
108 Commerce St.
Suite 105
Lake Mary,  FL  32746
Applicant Contact VICTOR RAGUCCI
Correspondent
Dynamic Marketing Ent.
108 Commerce St.
Suite 105
Lake Mary,  FL  32746
Correspondent Contact VICTOR RAGUCCI
Regulation Number878.4040
Classification Product Code
LYU  
Date Received03/14/1990
Decision Date 07/10/1990
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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