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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 K101262
Device Name FLEXI-LITE
Applicant
PRESSURE-TECH, INC.
55 Northern Blvd
Suite 200
Great Neck,  NY  11021
Applicant Contact MARIA GRIFFIN
Correspondent
UNDERWRITERS LABORATORIES, INC.
333 PFINGSTEN RD.
NORTHBROOK,  IL  60062
Correspondent Contact NED DEVINE
Regulation Number868.5470
Classification Product Code
CBF  
Date Received05/05/2010
Decision Date 06/10/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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