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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Intrafallopian Cannula
510(k) Number K000620
Device Name PBN FALLOPIAN TUBE CATHETER SYSTEM
Applicant
Medical Device Technologies, Inc.
3600 S.W 47th Ave.
Gainesville,  FL  32608
Applicant Contact KARL SWARTZ
Correspondent
Medical Device Technologies, Inc.
3600 S.W 47th Ave.
Gainesville,  FL  32608
Correspondent Contact KARL SWARTZ
Regulation Number884.4530
Classification Product Code
MDG  
Date Received02/24/2000
Decision Date 10/30/2000
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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