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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
Applicant Contact R.SAM NIEDBALA
Correspondent
OraSure Technologies, Inc.
1745 Eaton Ave.
Bethlehem,  PA  18018
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
Predetermined Change
Control Plan Authorized		 No
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