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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name pump, portable, aspiration (manual or powered)
510(k) Number K841903
Device Name FRASER HARLAKE EMERG. CARE SUCTION SYS
Applicant
FRASER HARLAKE, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
FRASER HARLAKE, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number878.4780
Classification Product Code
BTA  
Date Received05/07/1984
Decision Date 06/14/1984
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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