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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Acid, Lactic, Enzymatic Method
510(k) Number K913330
Device Name URINE COLLECTION KIT/DEVICE
Applicant
MEDICAL IMPLEMENTS, INC.
11341 BUSINESS CENTER DR.
SUITE A
RICHMOND,  VA  23236
Applicant Contact JAMES M PARRISH
Correspondent
MEDICAL IMPLEMENTS, INC.
11341 BUSINESS CENTER DR.
SUITE A
RICHMOND,  VA  23236
Correspondent Contact JAMES M PARRISH
Regulation Number862.1450
Classification Product Code
KHP  
Date Received07/25/1991
Decision Date 08/26/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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