Last synced on 14 November 2025 at 11:06 pm

SMOOTH FIT

Page Type
Cleared 510(K)
510(k) Number
K941575
510(k) Type
Traditional
Applicant
HI-TEC IMPLANTS
Country
Israel
FDA Decision
Substantially Equivalent
Decision Date
11/17/1994
Days to Decision
231 days
Submission Type
Statement

SMOOTH FIT

Page Type
Cleared 510(K)
510(k) Number
K941575
510(k) Type
Traditional
Applicant
HI-TEC IMPLANTS
Country
Israel
FDA Decision
Substantially Equivalent
Decision Date
11/17/1994
Days to Decision
231 days
Submission Type
Statement