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SPACEMAKER SURGICAL BALLOON DISSECTOR, SPACEMAKER II SURGICAL BALLOON DISSECTOR, SAPHTRAK

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K973046
510(k) Type
Traditional
Applicant
GENERAL SURGICAL INNOVATIONS
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
1/16/1998
Days to Decision
154 days
Submission Type
Summary