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REP HDL-8 KIT, NO. 3188, REP HDL-16 KIT, NO. 3187

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K894366
510(k) Type
Traditional
Applicant
HELENA LABORATORIES
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
8/31/1989
Days to Decision
48 days

REP HDL-8 KIT, NO. 3188, REP HDL-16 KIT, NO. 3187

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K894366
510(k) Type
Traditional
Applicant
HELENA LABORATORIES
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
8/31/1989
Days to Decision
48 days