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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 K001524
Device Name FORMA SCIENTIFIC DIRECT HEAT INCUBATORS
Applicant
Thermoquest Corp.
Mill Creek Rd.
Marietta,  OH  45750
Applicant Contact RICHARD L MILLER
Correspondent
Thermoquest Corp.
Mill Creek Rd.
Marietta,  OH  45750
Correspondent Contact RICHARD L MILLER
Regulation Number884.6120
Classification Product Code
MQG  
Date Received05/16/2000
Decision Date 07/12/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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