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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laryngoscope, Rigid
510(k) Number K941319
Device Name THE WUSCOPE SYSTEM
Applicant
Achi Corp.
1522 Blackfoot Dr.
P.O. Box 3282
Fremont,  CA  94539
Applicant Contact HSIU C CHOU,M.D.
Correspondent
Achi Corp.
1522 Blackfoot Dr.
P.O. Box 3282
Fremont,  CA  94539
Correspondent Contact HSIU C CHOU,M.D.
Regulation Number868.5540
Classification Product Code
CCW  
Date Received03/18/1994
Decision Date 10/04/1994
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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