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THE SPACEMAKER AND THE SPACEMAKER II

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K944418
510(k) Type
Traditional
Applicant
GENERAL SURGICAL INNOVATIONS
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
11/1/1994
Days to Decision
54 days
Submission Type
Summary

THE SPACEMAKER AND THE SPACEMAKER II

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K944418
510(k) Type
Traditional
Applicant
GENERAL SURGICAL INNOVATIONS
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
11/1/1994
Days to Decision
54 days
Submission Type
Summary