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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bur, Surgical, General & Plastic Surgery
510(k) Number K821485
Device Name DERMABRADERS
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 Number878.4820
Classification Product Code
GFF  
Date Received05/18/1982
Decision Date 06/10/1982
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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