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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name nebulizer, medicinal, non-ventilatory (atomizer)
510(k) Number K922033
Device Name SALINE SOLUTION- STERILE
Applicant
TRINITY LABORATORIES, INC.
201 KILEY DR.
SALISBURY,  MD  21801
Applicant Contact PARTHA BASUMALLIK
Correspondent
TRINITY LABORATORIES, INC.
201 KILEY DR.
SALISBURY,  MD  21801
Correspondent Contact PARTHA BASUMALLIK
Regulation Number868.5640
Classification Product Code
CCQ  
Date Received05/01/1992
Decision Date 07/21/1992
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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