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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bur, Ear, Nose And Throat
510(k) Number K802503
Device Name MICRO-SUGICAL POWER INSTRUMENT SYSTEM
Applicant
Spire Medical, Inc.
1884 Eastman Ave., #105
Ventura,  CA  93003
Applicant Contact DAVID C ESSLINGER
Correspondent
Spire Medical, Inc.
1884 Eastman Ave., #105
Ventura,  CA  93003
Correspondent Contact DAVID C ESSLINGER
Regulation Number874.4140
Classification Product Code
EQJ  
Date Received10/17/1980
Decision Date 10/31/1980
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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