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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instrument, Manual, Surgical, General Use
510(k) Number K941193
Device Name EAST WEST INSTRUMENTS
Applicant
East West Instruments, Inc.
1062 N. Highland Ave.
Aurora,  IL  60506
Applicant Contact TAHIR CHOUDHRY
Correspondent
East West Instruments, Inc.
1062 N. Highland Ave.
Aurora,  IL  60506
Correspondent Contact TAHIR CHOUDHRY
Regulation Number878.4800
Classification Product Code
MDM  
Date Received03/11/1994
Decision Date 11/09/1994
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
Predetermined Change
Control Plan Authorized		 No
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