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MODEL 8-B WITH LA-2B ATTACHMENT FOR OB-GYN USE

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K861845
510(k) Type
Traditional
Applicant
DIRECTED ENERGY, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
8/11/1986
Days to Decision
90 days

MODEL 8-B WITH LA-2B ATTACHMENT FOR OB-GYN USE

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K861845
510(k) Type
Traditional
Applicant
DIRECTED ENERGY, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
8/11/1986
Days to Decision
90 days