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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 K843693
Device Name JACOBS HIGH VACUUM SUCTION UNIT 05-2570
Applicant
J. SKLAR MFG. CO., INC.
38-04 WOODSIDE AVE.
LONG ISLAND CITY,  NY  11101
Applicant Contact ARNOLD E GORMAN
Correspondent
J. SKLAR MFG. CO., INC.
38-04 WOODSIDE AVE.
LONG ISLAND CITY,  NY  11101
Correspondent Contact ARNOLD E GORMAN
Regulation Number878.4780
Classification Product Code
BTA  
Date Received09/19/1984
Decision Date 10/31/1984
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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