Last synced on 30 September 2022 at 11:05 pm

SPIFE

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K972274
510(k) Type
Traditional
Applicant
HELENA LABORATORIES
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
10/27/1997
Days to Decision
131 days
Submission Type
Statement

SPIFE

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K972274
510(k) Type
Traditional
Applicant
HELENA LABORATORIES
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
10/27/1997
Days to Decision
131 days
Submission Type
Statement