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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Valve, Non-Rebreathing
510(k) Number K882204
Device Name RESUSCITATOR VALVE ASSEMBLY W/FILTER
Applicant
Intertech/Ohio
5030 Tice St.
Fort Myers,  FL  33905
Applicant Contact JAMES W POPE
Correspondent
Intertech/Ohio
5030 Tice St.
Fort Myers,  FL  33905
Correspondent Contact JAMES W POPE
Regulation Number868.5870
Classification Product Code
CBP  
Date Received05/25/1988
Decision Date 07/08/1988
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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