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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
510(k) Number K891572
Device Name ANGIOGRAPHY CUSTOM PACKS
Applicant
Procedure Packs, Inc.
15035 N. 73rd St.
Bldg. C
Scottsdale,  AZ  85260
Applicant Contact ROBERT S FUGATE
Correspondent
Procedure Packs, Inc.
15035 N. 73rd St.
Bldg. C
Scottsdale,  AZ  85260
Correspondent Contact ROBERT S FUGATE
Regulation Number870.4290
Classification Product Code
DTL  
Date Received03/20/1989
Decision Date 07/24/1989
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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