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SPIFE LD-12 KIT, MODEL 3338

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K022455
510(k) Type
Traditional
Applicant
HELENA LABORATORIES
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
10/1/2002
Days to Decision
67 days
Submission Type
Statement

SPIFE LD-12 KIT, MODEL 3338

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K022455
510(k) Type
Traditional
Applicant
HELENA LABORATORIES
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
10/1/2002
Days to Decision
67 days
Submission Type
Statement