Last synced on 25 January 2026 at 3:41 am

HYFRECATOR 2000

Page Type
Cleared 510(K)
PDF
PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K970493
510(k) Type
Traditional
Applicant
Aspen Labs
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
4/30/1997
Days to Decision
79 days
Submission Type
Statement

HYFRECATOR 2000

Page Type
Cleared 510(K)
PDF
PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K970493
510(k) Type
Traditional
Applicant
Aspen Labs
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
4/30/1997
Days to Decision
79 days
Submission Type
Statement