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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Accessory Equipment, Cardiopulmonary Bypass
510(k) Number K922404
Device Name TUBE GRIP
Applicant
Georgia Medical Products, Inc.
4390 Bishop Lake Rd.
Marietta,  GA  30062
Applicant Contact STEVEN L DOWNING
Correspondent
Georgia Medical Products, Inc.
4390 Bishop Lake Rd.
Marietta,  GA  30062
Correspondent Contact STEVEN L DOWNING
Regulation Number870.4200
Classification Product Code
KRI  
Date Received05/21/1992
Decision Date 11/23/1992
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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