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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K863065
Device Name HDL CHOLESTEROL-E
Applicant
J. D. Assoc.
163 Montclair Ave.
Montclair,  NJ  07042
Applicant Contact DI PIETRO
Correspondent
J. D. Assoc.
163 Montclair Ave.
Montclair,  NJ  07042
Correspondent Contact DI PIETRO
Date Received08/12/1986
Decision Date 09/25/1986
Decision Substantially Equivalent (SESE)
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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