Last synced on 25 November 2022 at 11:04 pm

BIOPSY GUIDE KIT FOR 8808 AND BIPLANE, ENDFIRE AND DUAL BIOPSY GUIDES FOR 8818

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K081323
510(k) Type
Traditional
Applicant
B-K MEDICAL APS
Country
Denmark
FDA Decision
Substantially Equivalent
Decision Date
7/22/2008
Days to Decision
71 days
Submission Type
Summary

BIOPSY GUIDE KIT FOR 8808 AND BIPLANE, ENDFIRE AND DUAL BIOPSY GUIDES FOR 8818

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K081323
510(k) Type
Traditional
Applicant
B-K MEDICAL APS
Country
Denmark
FDA Decision
Substantially Equivalent
Decision Date
7/22/2008
Days to Decision
71 days
Submission Type
Summary