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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheters, Suction, Tracheobronchial
510(k) Number K871407
Device Name MECONIUM ASPIRATOR
Applicant
Intertech Resources, Inc.
5100 Tice St.
Fort Myers,  FL  33905
Applicant Contact JAMES W POPE
Correspondent
Intertech Resources, Inc.
5100 Tice St.
Fort Myers,  FL  33905
Correspondent Contact JAMES W POPE
Regulation Number868.6810
Classification Product Code
BSY  
Date Received04/08/1987
Decision Date 06/15/1987
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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