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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Clamp, Vascular
510(k) Number K894670
Device Name GENERAL SURGICAL INSTRUMENTS
Applicant
Nopa Instruments
519 W. Lancaster Ave.
Haverford,  PA  19041
Applicant Contact T. W STUART
Correspondent
Nopa Instruments
519 W. Lancaster Ave.
Haverford,  PA  19041
Correspondent Contact T. W STUART
Regulation Number870.4450
Classification Product Code
DXC  
Date Received06/02/1989
Decision Date 08/10/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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