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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ventilator, Emergency, Manual (Resuscitator)
510(k) Number K900577
Device Name 1ST RESPONSE REUSABLE MANUAL RESUSCITATOR (ADULT)
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 Number868.5915
Classification Product Code
BTM  
Date Received02/07/1990
Decision Date 07/16/1990
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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