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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tube, Tympanostomy, Porous Polyethylene
510(k) Number K900218
Device Name J&S HDL CHOLESTEROL PRECIPITATING REAGENT
Applicant
J.S. Medical Assoc.
19 Strathmore Rd.
Natick,  MA  01760
Applicant Contact MARSHALL E DEUTSCH
Correspondent
J.S. Medical Assoc.
19 Strathmore Rd.
Natick,  MA  01760
Correspondent Contact MARSHALL E DEUTSCH
Regulation Number874.3880
Classification Product Code
LBL  
Date Received01/17/1990
Decision Date 06/18/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
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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