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ALL SILICONE 2-WAY & 3-WAY FOLY BALLOON CATHETER AND NELATON CATHETER

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K980919
510(k) Type
Traditional
Applicant
FORTUNE MEDICAL INSTRUMENT CORP.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
3/31/1998
Days to Decision
20 days
Submission Type
Statement

ALL SILICONE 2-WAY & 3-WAY FOLY BALLOON CATHETER AND NELATON CATHETER

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K980919
510(k) Type
Traditional
Applicant
FORTUNE MEDICAL INSTRUMENT CORP.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
3/31/1998
Days to Decision
20 days
Submission Type
Statement