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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Peripheral, Atherectomy
510(k) Number K924712
Device Name ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM
Applicant
Hearing Tech, Inc.
2515 140th Ave. NE
Bellevue,  WA  98005
Applicant Contact LOUISE C MYERS
Correspondent
Hearing Tech, Inc.
2515 140th Ave. NE
Bellevue,  WA  98005
Correspondent Contact LOUISE C MYERS
Regulation Number870.4875
Classification Product Code
MCW  
Date Received09/18/1992
Decision Date 12/08/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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