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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Formalin, Neutral Buffered
510(k) Number K872140
Device Name (MSI) PATH-SAVER
Applicant
Medical Specialties, Inc.
3610 Kennedy Rd.
South Plainfield,  NJ  07080
Applicant Contact RONALD DEVITA
Correspondent
Medical Specialties, Inc.
3610 Kennedy Rd.
South Plainfield,  NJ  07080
Correspondent Contact RONALD DEVITA
Regulation Number864.4010
Classification Product Code
IFP  
Date Received06/02/1987
Decision Date 06/15/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Pathology
510k Review Panel Pathology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
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