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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Connector, Airway (Extension)
510(k) Number K895144
Device Name INTERTECH METERED DOSE ELBOW
Applicant
INTERTECH/OHIO
5030 TICE ST.
FORT MYERS,  FL  33905
Applicant Contact JAMES POPE
Correspondent
INTERTECH/OHIO
5030 TICE ST.
FORT MYERS,  FL  33905
Correspondent Contact JAMES POPE
Regulation Number868.5810
Classification Product Code
BZA  
Date Received08/18/1989
Decision Date 10/19/1989
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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