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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pacemaker Lead Adaptor
510(k) Number K900605
Device Name 3.2-5MM UNIPOLAR LEAD UPSIZING KIT, MODEL AK 100
Applicant
Possis Medical, Inc.
8325 10th Ave. N.
Minneapolis,  MN  55427
Applicant Contact ROBERT J SCOTT
Correspondent
Possis Medical, Inc.
8325 10th Ave. N.
Minneapolis,  MN  55427
Correspondent Contact ROBERT J SCOTT
Regulation Number870.3620
Classification Product Code
DTD  
Date Received02/08/1990
Decision Date 03/06/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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