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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 K963377
Device Name EOS BRAND DISPOSABLE VAGINAL SPECULUM-EOSSPEC
Applicant
North Eos Industries, Inc.
54, Ln. 1, Been St.
Tung-Shih
Taichung Hsien,  TW
Applicant Contact SARA CHEN
Correspondent
North Eos Industries, Inc.
54, Ln. 1, Been St.
Tung-Shih
Taichung Hsien,  TW
Correspondent Contact SARA CHEN
Regulation Number884.4530
Classification Product Code
HIB  
Date Received08/27/1996
Decision Date 10/04/1996
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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