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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name yoke assembly, medical gas
510(k) Number K851215
Device Name T-HANDLE ADAPTER, U-HANDLE & L HANDLER ADAPTER
Applicant
PENOX TECHNOLOGIES, INC.
ONE PENOX PLAZA, COMMERCE RD.
P.O. BOX 785
PITTSTON,  PA  18640
Applicant Contact ALAN P SCHWARTZ
Correspondent
PENOX TECHNOLOGIES, INC.
ONE PENOX PLAZA, COMMERCE RD.
P.O. BOX 785
PITTSTON,  PA  18640
Correspondent Contact ALAN P SCHWARTZ
Regulation Number868.6885
Classification Product Code
CAM  
Date Received03/26/1985
Decision Date 06/18/1985
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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