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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Drain, Tee (Water Trap)
510(k) Number K946057
Device Name AQUALARM MOISTURE SENSOR MODEL P85000
Applicant
Pegasus Research Corp.
775 W. 17th St. Suite D
Costa Mesa,  CA  92627
Applicant Contact KENNETH G MILLER
Correspondent
Pegasus Research Corp.
775 W. 17th St. Suite D
Costa Mesa,  CA  92627
Correspondent Contact KENNETH G MILLER
Regulation Number868.5995
Classification Product Code
BYH  
Date Received12/12/1994
Decision Date 05/05/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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