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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pump, Infusion, Analytical Sampling
510(k) Number K882830
Device Name INFUSION PUMP
Applicant
Pemlab Corp.
3770 Tansy St.
San Diego,  CA  92121
Applicant Contact BARNEY PARKER
Correspondent
Pemlab Corp.
3770 Tansy St.
San Diego,  CA  92121
Correspondent Contact BARNEY PARKER
Regulation Number880.5725
Classification Product Code
LZF  
Date Received07/08/1988
Decision Date 12/30/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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