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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 K973268
Device Name MICROAIRE POWER ASPIRATION DEVICE PAD SYSTEM
Applicant
MICROAIRE SURGICAL INSTRUMENTS, INC.
1641 EDLICH DR.
CHARLOTTESVILLE,  VA  22911
Applicant Contact CCARL ANGLES
Correspondent
MICROAIRE SURGICAL INSTRUMENTS, INC.
1641 EDLICH DR.
CHARLOTTESVILLE,  VA  22911
Correspondent Contact CCARL ANGLES
Regulation Number878.4780
Classification Product Code
BTA  
Date Received08/29/1997
Decision Date 11/26/1997
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
Recalls CDRH Recalls
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