Last synced on 30 September 2022 at 11:05 pm

MODEL 10-C W/LP-10A/U & OB-10A/U FOR ORAL/ENT USE

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K862865
510(k) Type
Traditional
Applicant
DIRECTED ENERGY, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
1/9/1987
Days to Decision
164 days

MODEL 10-C W/LP-10A/U & OB-10A/U FOR ORAL/ENT USE

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K862865
510(k) Type
Traditional
Applicant
DIRECTED ENERGY, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
1/9/1987
Days to Decision
164 days