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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Suspension, Cell Culture
510(k) Number K875221
Device Name TOOTH PRESERVING SYSTEM
Applicant
Biological Rescue Products, Inc.
22 N. Price St.
Pottstown,  PA  19464
Applicant Contact PAUL KRASNER
Correspondent
Biological Rescue Products, Inc.
22 N. Price St.
Pottstown,  PA  19464
Correspondent Contact PAUL KRASNER
Regulation Number864.2240
Classification Product Code
KJF  
Date Received12/22/1987
Decision Date 04/14/1988
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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