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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name sleeve, limb, compressible
510(k) Number K951684
Device Name AIRPERFECT 1000 (SINGLE-USER SYSTEM), AIRPERFECT 2000 (MULTI-USER SYSTEM)
Applicant
DIGITAL AIR CORP.
3003 LBJ FREEWAY
SUITE 100
DALLAS,  TX  75234 -7755
Applicant Contact STAN E TILLMAN
Correspondent
DIGITAL AIR CORP.
3003 LBJ FREEWAY
SUITE 100
DALLAS,  TX  75234 -7755
Correspondent Contact STAN E TILLMAN
Regulation Number870.5800
Classification Product Code
JOW  
Date Received04/11/1995
Decision Date 10/06/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
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