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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Cleaner, Air, Medical Recirculating
510(k) Number K942512
Device Name PA300
Applicant
The Rival Co.
1001 Golden Dr.
Clinton,  MO  64735
Applicant Contact JAMES FERGUSON
Correspondent
The Rival Co.
1001 Golden Dr.
Clinton,  MO  64735
Correspondent Contact JAMES FERGUSON
Regulation Number880.5045
Classification Product Code
FRF  
Date Received05/26/1994
Decision Date 11/18/1994
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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