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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name unit, cryosurgical, accessories
510(k) Number K982358
Device Name HISTOFREEZER DEVICE
Applicant
ORASURE TECHNOLOGIES, INC.
1745 EATON AVE.
BETHLEHEM,  PA  18018 -1799
Applicant Contact R.SAM NIEDBALA
Correspondent
ORASURE TECHNOLOGIES, INC.
1745 EATON AVE.
BETHLEHEM,  PA  18018 -1799
Correspondent Contact R.SAM NIEDBALA
Regulation Number878.4350
Classification Product Code
GEH  
Date Received07/06/1998
Decision Date 10/02/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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