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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Trocar
510(k) Number K840529
Device Name STEIGER TUNNELING INSTRUMENT 285
Applicant
EVERMED, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
EVERMED, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number870.1390
Classification Product Code
DRC  
Date Received02/08/1984
Decision Date 03/12/1984
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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