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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Sera, Animal And Human
510(k) Number K872847
Device Name SOLCOSERYL TISSUE CULTURE GROWTH SUPPLEMENT
Applicant
Candace Lane Corp.
140 Littleton Rd.
Suite 301
Parsippany,  NJ  07054
Applicant Contact WOLFGANG JOCHLE
Correspondent
Candace Lane Corp.
140 Littleton Rd.
Suite 301
Parsippany,  NJ  07054
Correspondent Contact WOLFGANG JOCHLE
Regulation Number864.2800
Classification Product Code
KIS  
Date Received07/20/1987
Decision Date 08/10/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Pathology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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