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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 K895549
Device Name M.D.I. ADAPTER
Applicant
Custom Connection Corp.
100 Bramblewood Ln.
Braintree,  MA  02184
Applicant Contact JOHN QUINN
Correspondent
Custom Connection Corp.
100 Bramblewood Ln.
Braintree,  MA  02184
Correspondent Contact JOHN QUINN
Regulation Number868.5810
Classification Product Code
BZA  
Date Received09/13/1989
Decision Date 11/21/1989
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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