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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Syringe, Piston
510(k) Number K882975
Device Name RE-VENT ARTERIAL BLOOD SAMPLER AND/OR BIOSAMPLER
Applicant
Richmann Laboratories
1334 S. Killian Dr.
P.O. Box 12958
Lake Park,  FL  33403
Applicant Contact REED
Correspondent
Richmann Laboratories
1334 S. Killian Dr.
P.O. Box 12958
Lake Park,  FL  33403
Correspondent Contact REED
Regulation Number880.5860
Classification Product Code
FMF  
Date Received07/15/1988
Decision Date 01/25/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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