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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Rebreathing
510(k) Number K895274
Device Name HYPEX
Applicant
Global Business, Inc.
2121 Castlebridge Rd.
Midlothian,  VA  23113
Applicant Contact LENKEY III
Correspondent
Global Business, Inc.
2121 Castlebridge Rd.
Midlothian,  VA  23113
Correspondent Contact LENKEY III
Regulation Number868.5675
Classification Product Code
BYW  
Date Received08/23/1989
Decision Date 02/23/1990
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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