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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Unit, Liquid-Oxygen, Portable
510(k) Number K860738
Device Name CTC 30, 40, 1 LIQUID OXYGEN LITERS
Applicant
Cryodyne Technologies, Inc.
3541 State Rd. 710
Riviera Beach,  FL  33404
Applicant Contact DAVID E SMITH
Correspondent
Cryodyne Technologies, Inc.
3541 State Rd. 710
Riviera Beach,  FL  33404
Correspondent Contact DAVID E SMITH
Regulation Number868.5655
Classification Product Code
BYJ  
Date Received02/27/1986
Decision Date 08/06/1986
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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