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DISPOSABLE AMNIOTOME

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K883283
510(k) Type
Traditional
Applicant
GALENICA ENTERPRISES, INC.
Country
Canada
FDA Decision
Substantially Equivalent
Decision Date
10/18/1988
Days to Decision
75 days

DISPOSABLE AMNIOTOME

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K883283
510(k) Type
Traditional
Applicant
GALENICA ENTERPRISES, INC.
Country
Canada
FDA Decision
Substantially Equivalent
Decision Date
10/18/1988
Days to Decision
75 days