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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 K880439
Device Name PROTECT-AIDS UNDERGLOVE
Applicant
Medical Armor Corp.
11515 Eidelweiss St., NW
Minneapolis,  MN  55433
Applicant Contact DWIGHT K GAHM
Correspondent
Medical Armor Corp.
11515 Eidelweiss St., NW
Minneapolis,  MN  55433
Correspondent Contact DWIGHT K GAHM
Regulation Number878.4040
Classification Product Code
LYU  
Date Received02/02/1988
Decision Date 10/11/1988
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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