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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Material, Impression
510(k) Number K854855
Device Name PROOF ALGINATE IMPRESSION MATERIAL
Applicant
Sybron Corp.
P.O. Box 455
28200 Wick Rd.
Romulus,  MI  48174
Applicant Contact BENJAMIN WEAVER
Correspondent
Sybron Corp.
P.O. Box 455
28200 Wick Rd.
Romulus,  MI  48174
Correspondent Contact BENJAMIN WEAVER
Regulation Number872.3660
Classification Product Code
ELW  
Date Received12/05/1985
Decision Date 01/30/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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