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PRECISION ENDOSCOPIC INFRARED COAGULATOR; MODEL 5100 SINGLE- USE DISPOSABLE MAXI-GUIDE FLEXIBLE LIGHTGUIDE; MODEL 5100-2

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K083275
510(k) Type
Traditional
Applicant
MAX ENDOSCOPY INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
6/9/2009
Days to Decision
215 days
Submission Type
Statement

PRECISION ENDOSCOPIC INFRARED COAGULATOR; MODEL 5100 SINGLE- USE DISPOSABLE MAXI-GUIDE FLEXIBLE LIGHTGUIDE; MODEL 5100-2

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K083275
510(k) Type
Traditional
Applicant
MAX ENDOSCOPY INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
6/9/2009
Days to Decision
215 days
Submission Type
Statement