Last synced on 23 September 2022 at 11:05 pm

REP TM SPE (PONCEAU S) PROCEDURES

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K894585
510(k) Type
Traditional
Applicant
HELENA LABORATORIES
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
9/13/1989
Days to Decision
51 days

REP TM SPE (PONCEAU S) PROCEDURES

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K894585
510(k) Type
Traditional
Applicant
HELENA LABORATORIES
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
9/13/1989
Days to Decision
51 days