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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Circuit, Breathing (W Connector, Adaptor, Y Piece)
510(k) Number K912065
Device Name DISPOSABLE ANESTHESIA BREATHING CIRCUITS, MODIFIED
Applicant
INTERTECH RESOURCES, INC.
5100 TICE ST.
FT. MYERS,  FL  33905
Applicant Contact DEBRA E ROGERS
Correspondent
INTERTECH RESOURCES, INC.
5100 TICE ST.
FT. MYERS,  FL  33905
Correspondent Contact DEBRA E ROGERS
Regulation Number868.5240
Classification Product Code
CAI  
Date Received04/26/1991
Decision Date 10/23/1991
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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