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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Arterial Blood Sampling Kit
510(k) Number K954035
Device Name ACTI-FLEX ARTERIAL EXTENSION SET
Applicant
R-Group Intl.
2321 NW 66th Ct., Suite W-4
Gainesville,  FL  32653
Applicant Contact KERRY ANNE KAHN
Correspondent
R-Group Intl.
2321 NW 66th Ct., Suite W-4
Gainesville,  FL  32653
Correspondent Contact KERRY ANNE KAHN
Regulation Number868.1100
Classification Product Code
CBT  
Date Received08/28/1995
Decision Date 09/25/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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