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IMPAX 5000

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K934386
510(k) Type
Traditional
Applicant
HERAEUS KULZER, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
1/5/1994
Days to Decision
119 days
Submission Type
Statement

IMPAX 5000

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K934386
510(k) Type
Traditional
Applicant
HERAEUS KULZER, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
1/5/1994
Days to Decision
119 days
Submission Type
Statement