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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 K051759
Device Name FLEXI-LITE, MODEL FL-V1.2
Applicant
Performance Hyperbarics
2599 A Olinda Rd.
Makawao,  HI  96768
Applicant Contact SPENCER FELDMAN
Correspondent
Performance Hyperbarics
2599 A Olinda Rd.
Makawao,  HI  96768
Correspondent Contact SPENCER FELDMAN
Regulation Number868.5470
Classification Product Code
CBF  
Date Received06/29/2005
Decision Date 11/17/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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