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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name ventilator, non-continuous (respirator)
510(k) Number K991926
Device Name OPAP
Applicant
OPAP, INC.
26037 SUGAR PINE DR.
PIONEER,  CA  95666 -0189
Applicant Contact WILLIAM T HART
Correspondent
OPAP, INC.
26037 SUGAR PINE DR.
PIONEER,  CA  95666 -0189
Correspondent Contact WILLIAM T HART
Regulation Number868.5905
Classification Product Code
BZD  
Date Received06/07/1999
Decision Date 10/18/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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