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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Resuscitator, Manual, Non Self-Inflating
510(k) Number K001714
Device Name MERCURY MEDICAL HYPERINFLATION BAG SYSTEM, MODEL 83-900-0149
Applicant
Mercury Medical
11300 49th St. N.
Clearwater,  FL  33762
Applicant Contact RON RUPENSKI
Correspondent
Mercury Medical
11300 49th St. N.
Clearwater,  FL  33762
Correspondent Contact RON RUPENSKI
Regulation Number868.5905
Classification Product Code
NHK  
Date Received06/05/2000
Decision Date 11/03/2000
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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