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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
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