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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 K940820
Device Name PERSHIELD CPR DEVICE
Applicant
Rabintex Industries, Ltd.
3 Baruch Hirst St.
Bnei-Brak 51201 Israel,  IL
Applicant Contact GARY RASHBA
Correspondent
Rabintex Industries, Ltd.
3 Baruch Hirst St.
Bnei-Brak 51201 Israel,  IL
Correspondent Contact GARY RASHBA
Regulation Number868.5870
Classification Product Code
CBP  
Date Received02/22/1994
Decision Date 09/25/1995
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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