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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Percutaneous
510(k) Number K821480
Device Name RIGHT ATRIAL CATHETERS PARENTERAL NUTRIT
Applicant
The Healthcare Group Laboratories, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
The Healthcare Group Laboratories, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number870.1250
Classification Product Code
DQY  
Date Received05/18/1982
Decision Date 06/17/1982
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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