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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Compressor, Air, Portable
510(k) Number K863339
Device Name DURA NEB(TM) 2000 PORTABLE COMPRESSOR
Applicant
THERA TEC, INC.
12795 KINGFISH AVE.
TREASURE ISLAND,  FL  33706
Applicant Contact JACK GOSS
Correspondent
THERA TEC, INC.
12795 KINGFISH AVE.
TREASURE ISLAND,  FL  33706
Correspondent Contact JACK GOSS
Regulation Number868.6250
Classification Product Code
BTI  
Date Received08/28/1986
Decision Date 10/07/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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