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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Set, Tubing And Support, Ventilator (W Harness)
510(k) Number K952010
Device Name PRIMA VENTILATOR HOSES
Applicant
PRIMA, INC.
1300 25TH ST. PLAZA
SUITE 11
CLEVELAND,  TN  37311
Applicant Contact ROBERT STEINBARGER
Correspondent
PRIMA, INC.
1300 25TH ST. PLAZA
SUITE 11
CLEVELAND,  TN  37311
Correspondent Contact ROBERT STEINBARGER
Regulation Number868.5975
Classification Product Code
BZO  
Date Received04/28/1995
Decision Date 05/22/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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