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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 K912457
Device Name MEDARMOR FINGERTIP, PUNCTURE AND CUT RESISTANT GLO
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 Received06/03/1991
Decision Date 10/04/1991
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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