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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 K974228
Device Name HOSPITAL'S SPEC
Applicant
GPS
11 LOWELL RD.
PORT WASHINGTON,  NY  11050
Applicant Contact LOUIS PAGLIARA
Correspondent
GPS
11 LOWELL RD.
PORT WASHINGTON,  NY  11050
Correspondent Contact LOUIS PAGLIARA
Regulation Number884.4530
Classification Product Code
HIB  
Date Received11/12/1997
Decision Date 12/12/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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