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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name drill, surgical, ent (electric or pneumatic) including handpiece
510(k) Number K802463
Device Name MICRO-SURGICAL 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 Number874.4250
Classification Product Code
ERL  
Date Received10/09/1980
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
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