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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Set, Tubing And Support, Ventilator (W Harness)
510(k) Number K922479
Device Name DISPOSABLE ANESTHESIA BREATHING CIRCUIT, MODIFIED
Applicant
INTERTECH RESOURCES, INC.
5100 TICE ST.
FT. MYERS,  FL  33905
Applicant Contact POPE
Correspondent
INTERTECH RESOURCES, INC.
5100 TICE ST.
FT. MYERS,  FL  33905
Correspondent Contact POPE
Regulation Number868.5975
Classification Product Code
BZO  
Date Received05/26/1992
Decision Date 10/30/1992
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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