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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
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