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REP SPE PLUS (PONCEAU S) SYSTEM, 3163, 3164 & 3165

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K912386
510(k) Type
Traditional
Applicant
HELENA LABORATORIES
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
7/17/1991
Days to Decision
82 days
Submission Type
Statement

REP SPE PLUS (PONCEAU S) SYSTEM, 3163, 3164 & 3165

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K912386
510(k) Type
Traditional
Applicant
HELENA LABORATORIES
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
7/17/1991
Days to Decision
82 days
Submission Type
Statement