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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 WEST 17TH ST. STE.D
COSTA MESA,  CA  92627
Applicant Contact KENNETH G MILLER
Correspondent
PEGASUS RESEARCH CORP.
775 WEST 17TH ST. STE.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
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