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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Speculum, Vaginal, Nonmetal
510(k) Number K903744
Device Name PHYSICIAN'S CHOICE
Applicant
Advance Medical Device, Inc.
15 Valley Trl.,
R.R. #1, Newmarket,
Ontario L3y 4v8, Canada,  CA
Applicant Contact ROBERT G DICKIE
Correspondent
Advance Medical Device, Inc.
15 Valley Trl.,
R.R. #1, Newmarket,
Ontario L3y 4v8, Canada,  CA
Correspondent Contact ROBERT G DICKIE
Regulation Number884.4530
Classification Product Code
HIB  
Date Received08/16/1990
Decision Date 09/12/1990
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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