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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Chamber, Hyperbaric
510(k) Number K861315
Device Name HYPERBARIC PENETRATION EXTENSION SET
Applicant
Cutter Laboratories, Inc.
Fourth And Parker St.s
Box 1986
Berkeley,  CA  94710
Applicant Contact STEVEN J OJALA
Correspondent
Cutter Laboratories, Inc.
Fourth And Parker St.s
Box 1986
Berkeley,  CA  94710
Correspondent Contact STEVEN J OJALA
Regulation Number868.5470
Classification Product Code
CBF  
Date Received04/08/1986
Decision Date 05/21/1986
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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