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REP(R) SPE TEMPLATE 30, 16, & 8

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K913807
510(k) Type
Traditional
Applicant
HELENA LABORATORIES
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
11/27/1991
Days to Decision
93 days
Submission Type
Statement

REP(R) SPE TEMPLATE 30, 16, & 8

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K913807
510(k) Type
Traditional
Applicant
HELENA LABORATORIES
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
11/27/1991
Days to Decision
93 days
Submission Type
Statement