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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 K851219
Device Name FILL HOSE SAFETY 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
Predetermined Change
Control Plan Authorized		 No
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