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AQUA+I-F, I-H, I-FH, II-H, II-FH, III-H

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K945359
510(k) Type
Traditional
Applicant
ARTEMA MEDICAL AB
Country
Sweden
FDA Decision
Substantially Equivalent
Decision Date
2/21/1995
Days to Decision
111 days
Submission Type
Statement

AQUA+I-F, I-H, I-FH, II-H, II-FH, III-H

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K945359
510(k) Type
Traditional
Applicant
ARTEMA MEDICAL AB
Country
Sweden
FDA Decision
Substantially Equivalent
Decision Date
2/21/1995
Days to Decision
111 days
Submission Type
Statement