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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laparoscope, Gynecologic (And Accessories)
510(k) Number K933008
Device Name RETRACTORS AND SCRAPER
Applicant
BAXTER HEALTHCARE CORP.
1435 LAKE COOK RD.
DEERFIELD,  IL  60015
Applicant Contact NICOLE M CLARK
Correspondent
BAXTER HEALTHCARE CORP.
1435 LAKE COOK RD.
DEERFIELD,  IL  60015
Correspondent Contact NICOLE M CLARK
Regulation Number884.1720
Classification Product Code
HET  
Date Received06/21/1993
Decision Date 03/11/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
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