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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mask, Oxygen, Non-Rebreathing
510(k) Number K970688
Device Name POCKET RESCUE
Applicant
Cheen Houng Ent. Co. , Ltd.
23 Aly. 11 Ln. 65 San Dreen
St.
Taipei (Shulin),  TW 23805
Applicant Contact JAY WANG
Correspondent
Cheen Houng Ent. Co. , Ltd.
23 Aly. 11 Ln. 65 San Dreen
St.
Taipei (Shulin),  TW 23805
Correspondent Contact JAY WANG
Regulation Number868.5570
Classification Product Code
KGB  
Date Received02/25/1997
Decision Date 09/26/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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