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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K810029
Device Name REGULATOR VENOSET W/0.22 MICRON IVEX
Applicant
Abbott Laboratories
One Abbott Park Rd.
Abbott Park,  IL  60064 -3500
Correspondent
Abbott Laboratories
One Abbott Park Rd.
Abbott Park,  IL  60064 -3500
Date Received01/06/1981
Decision Date 01/06/1981
Decision SE - Postmarket Surveillance Required (SESP)
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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