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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Hyaline Membrane Disease Assay
510(k) Number K844637
Device Name WHITESIDE ACRYLIC CEMENT SPACER SLEEVE
Applicant
Dow Corning Corp. Healthcare Industries Materials
P.O. Box 1767 Midland,  MI  48640
Applicant Contact HARVEY L STEINBERG
Correspondent
Dow Corning Corp. Healthcare Industries Materials
P.O. Box 1767 Midland,  MI  48640
Correspondent Contact HARVEY L STEINBERG
Classification Product Code
LTC  
Date Received11/28/1984
Decision Date 06/19/1985
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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