Last synced on 30 September 2022 at 11:05 pm

REP SPE VIS-60/40 KIT

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K973316
510(k) Type
Traditional
Applicant
HELENA LABORATORIES
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
10/1/1997
Days to Decision
28 days
Submission Type
Statement

REP SPE VIS-60/40 KIT

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K973316
510(k) Type
Traditional
Applicant
HELENA LABORATORIES
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
10/1/1997
Days to Decision
28 days
Submission Type
Statement