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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 K891129
Device Name SERIES 3 GENERAL SUCTION SYSTEM
Applicant
Ultravac, Inc.
12344 Oak Knoll Rd.
Poway,  CA  92064
Applicant Contact TED PARISI
Correspondent
Ultravac, Inc.
12344 Oak Knoll Rd.
Poway,  CA  92064
Correspondent Contact TED PARISI
Regulation Number878.4780
Classification Product Code
BTA  
Date Received03/03/1989
Decision Date 09/25/1989
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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