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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name accessory, assisted reproduction
510(k) Number K021042
Device Name THERMO FORMA, CRYOMED, CONTROLLED RATE FREEZERS; MODELS # 7456, 7457, 7458,7459,7475,7476
Applicant
THERMO FORMA, INC.
401 MILLCREEK RD.
MARIETTA,  OH  45750
Applicant Contact RICHARD L MILLER
Correspondent
THERMO FORMA, INC.
401 MILLCREEK RD.
MARIETTA,  OH  45750
Correspondent Contact RICHARD L MILLER
Regulation Number884.6120
Classification Product Code
MQG  
Date Received04/01/2002
Decision Date 05/15/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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