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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 K921624
Device Name DISPOSABLE VOLUME VENT/ANESTHESIA BREATH CIRCUITS
Applicant
Intertech Resources, Inc.
5100 Tice St.
Fort Myers,  FL  33905
Applicant Contact ALYCE P MARSHALL
Correspondent
Intertech Resources, Inc.
5100 Tice St.
Fort Myers,  FL  33905
Correspondent Contact ALYCE P MARSHALL
Regulation Number868.5995
Classification Product Code
BYH  
Date Received04/06/1992
Decision Date 06/30/1992
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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