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CANDELA INTRODUCER SHEATH SYSTEM

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K912443
510(k) Type
Traditional
Applicant
CANDELA LASER CORP.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
8/16/1991
Days to Decision
74 days
Submission Type
Statement

CANDELA INTRODUCER SHEATH SYSTEM

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K912443
510(k) Type
Traditional
Applicant
CANDELA LASER CORP.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
8/16/1991
Days to Decision
74 days
Submission Type
Statement