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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name instrument, surgical, disposable
510(k) Number K920263
Device Name MANUAL SURGICAL INSTRUMENTS
Applicant
PHOENIX INSTRUMENTS DIV.
1020 FULLERTON AVE.
UNIT C
ADDISON,  IL  60101
Applicant Contact SHARON L FREEDMAN
Correspondent
PHOENIX INSTRUMENTS DIV.
1020 FULLERTON AVE.
UNIT C
ADDISON,  IL  60101
Correspondent Contact SHARON L FREEDMAN
Regulation Number878.4800
Classification Product Code
KDC  
Date Received01/21/1992
Decision Date 05/06/1992
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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