Last synced on 25 January 2026 at 3:41 am

AMBIDERM

Page Type
Cleared 510(K)
PDF
PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K971102
510(k) Type
Traditional
Applicant
Supertex Industrial, S.A. DE C.V.
Country
Mexico
FDA Decision
Substantially Equivalent
Decision Date
8/29/1997
Days to Decision
156 days
Submission Type
Statement

AMBIDERM

Page Type
Cleared 510(K)
PDF
PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K971102
510(k) Type
Traditional
Applicant
Supertex Industrial, S.A. DE C.V.
Country
Mexico
FDA Decision
Substantially Equivalent
Decision Date
8/29/1997
Days to Decision
156 days
Submission Type
Statement