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MODEL 8-B WITH OS-1 ATTACHMENT (C02 LASER FOR ENT)

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K862150
510(k) Type
Traditional
Applicant
DIRECTED ENERGY, INC.
Country
United States
FDA Decision
Substantially Equivalent for Some Indications
Decision Date
9/4/1986
Days to Decision
92 days

MODEL 8-B WITH OS-1 ATTACHMENT (C02 LASER FOR ENT)

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K862150
510(k) Type
Traditional
Applicant
DIRECTED ENERGY, INC.
Country
United States
FDA Decision
Substantially Equivalent for Some Indications
Decision Date
9/4/1986
Days to Decision
92 days