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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 K831085
Device Name SYNEVAC VACUUM SOURCE UNIT
Applicant
SYNEMED, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
SYNEMED, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number878.4780
Classification Product Code
BTA  
Date Received04/04/1983
Decision Date 06/08/1983
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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