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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Transducer, Ultrasonic, Obstetric
510(k) Number K862072
Device Name FETASCAN ULTRASOUND TRANSDUCER IBI# 101B00054-01
Applicant
INTERNATIONAL BIOMEDICS, INC.
1631 220TH AVE. S.E.
(PER DO, FIRM OOB)
BOTHELL,  WA  98021
Applicant Contact HOCHBERG, MD
Correspondent
INTERNATIONAL BIOMEDICS, INC.
1631 220TH AVE. S.E.
(PER DO, FIRM OOB)
BOTHELL,  WA  98021
Correspondent Contact HOCHBERG, MD
Regulation Number884.2960
Classification Product Code
HGL  
Date Received05/30/1986
Decision Date 07/09/1986
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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