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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name pump, portable, aspiration (manual or powered)
510(k) Number K980392
Device Name PSI-TEC ASPIRATOR
Applicant
BYRON MEDICAL
3280 E. HEMISPHERE LOOP
SUITE 100
TUCSON,  AZ  85706
Applicant Contact STEVE BOLLINGER
Correspondent
BYRON MEDICAL
3280 E. HEMISPHERE LOOP
SUITE 100
TUCSON,  AZ  85706
Correspondent Contact STEVE BOLLINGER
Regulation Number878.4780
Classification Product Code
BTA  
Subsequent Product Code
JCX  
Date Received02/02/1998
Decision Date 03/05/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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