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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Filter, Bacterial, Breathing-Circuit
510(k) Number K952015
Device Name PRIMA FILTER
Applicant
Prima, Inc.
1300 25th St. Plz.
Suite 11
Cleveland,  TN  37311
Applicant Contact ROBERT STEINBARGER
Correspondent
Prima, Inc.
1300 25th St. Plz.
Suite 11
Cleveland,  TN  37311
Correspondent Contact ROBERT STEINBARGER
Regulation Number868.5260
Classification Product Code
CAH  
Date Received04/28/1995
Decision Date 05/22/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
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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