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

Page Type
Cleared 510(K)
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

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

Page Type
Cleared 510(K)
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