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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 K002971
Device Name MTG - MINITUB HEATED STAGE SYSTEMS
Applicant
Zander Medical Supplies, Inc.
755 8th Ct., Suite #4
P.O.650790
Vero Beach,  FL  32965 -0790
Applicant Contact FRIEDEL MW ZANDER
Correspondent
Zander Medical Supplies, Inc.
755 8th Ct., Suite #4
P.O.650790
Vero Beach,  FL  32965 -0790
Correspondent Contact FRIEDEL MW ZANDER
Regulation Number884.6120
Classification Product Code
MQG  
Date Received09/22/2000
Decision Date 12/15/2000
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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