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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laparoscope, General & Plastic Surgery
510(k) Number K990785
Device Name TROCAR & TROCAR SLEEVES, LAPAROSCOPES, LAPAROSCOPIC FORCEPS, & LAPAROSCOPIC INSTRUMENTS
Applicant
JAKOUBEK MEDIZINTECHNIK GMBH
1822 N. STRATFORD RD.
ARLINGTON HTS.,  IL  60004
Applicant Contact DOUGLAS HULFISH
Correspondent
JAKOUBEK MEDIZINTECHNIK GMBH
1822 N. STRATFORD RD.
ARLINGTON HTS.,  IL  60004
Correspondent Contact DOUGLAS HULFISH
Regulation Number876.1500
Classification Product Code
GCJ  
Subsequent Product Code
GEI  
Date Received03/09/1999
Decision Date 08/27/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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