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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Forceps
510(k) Number K895212
Device Name TIK EXTRAKTOR
Applicant
INSTRUMENTS OF SWEDEN, INC.
134 DAVENPORT DR.
STAMFORD,  CT  06902
Applicant Contact WILLIAM J TOBIN
Correspondent
INSTRUMENTS OF SWEDEN, INC.
134 DAVENPORT DR.
STAMFORD,  CT  06902
Correspondent Contact WILLIAM J TOBIN
Regulation Number878.4800
Classification Product Code
HTD  
Date Received08/18/1989
Decision Date 09/27/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
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