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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stages, Microscope
510(k) Number K881467
Device Name MICROSCOPE STAGE HEATER
Applicant
Cryodyne Technologies, Inc.
400 Hoover Rd.
Soquel,  CA  95073
Applicant Contact DEAN W SCHILLING
Correspondent
Cryodyne Technologies, Inc.
400 Hoover Rd.
Soquel,  CA  95073
Correspondent Contact DEAN W SCHILLING
Regulation Number864.3600
Classification Product Code
KEJ  
Date Received04/06/1988
Decision Date 04/18/1988
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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