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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 K912737
Device Name MEDARMOR FINGERTIP, PUNC/CUT RESIST SURG EXAM GLOV
Applicant
Medical Armor Corp.
P.O. Box 708
Fremont,  MD  68025
Applicant Contact DWIGHT K GAHM
Correspondent
Medical Armor Corp.
P.O. Box 708
Fremont,  MD  68025
Correspondent Contact DWIGHT K GAHM
Regulation Number878.4040
Classification Product Code
LYU  
Date Received06/21/1991
Decision Date 10/08/1991
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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