Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name bit, surgical
510(k) Number K821486
Device Name MICRO DRILLS
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
GFG  
Date Received05/18/1982
Decision Date 06/09/1982
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
-
-