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ENDOLUMINA II TRANSILLUMINATION SYSTEM 56FR E-5630, 50FR E-5030 AND 40FR E-4020, ENDOLUMINA II DETACHABLE TIPS, 56FR, TA

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K964561
510(k) Type
Traditional
Applicant
BIOENTERICS CORP.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
2/11/1997
Days to Decision
90 days
Submission Type
Summary

ENDOLUMINA II TRANSILLUMINATION SYSTEM 56FR E-5630, 50FR E-5030 AND 40FR E-4020, ENDOLUMINA II DETACHABLE TIPS, 56FR, TA

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K964561
510(k) Type
Traditional
Applicant
BIOENTERICS CORP.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
2/11/1997
Days to Decision
90 days
Submission Type
Summary