Last synced on 4 February 2023 at 10:33 pm

QUADRASPHERE 30 TO 60

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K113822
510(k) Type
Special
Applicant
BIOSPHERE MEDICAL, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
3/8/2012
Days to Decision
72 days
Submission Type
Summary

QUADRASPHERE 30 TO 60

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K113822
510(k) Type
Special
Applicant
BIOSPHERE MEDICAL, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
3/8/2012
Days to Decision
72 days
Submission Type
Summary