Last synced on 18 April 2025 at 11:05 pm

MODIFICATION OF: SPHERO FLEX, PIVOT FLEX, AND SPHERO BLOCK

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K033630
510(k) Type
Special
Applicant
RHEIN 83 SRL
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
4/21/2004
Days to Decision
156 days
Submission Type
Statement

MODIFICATION OF: SPHERO FLEX, PIVOT FLEX, AND SPHERO BLOCK

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K033630
510(k) Type
Special
Applicant
RHEIN 83 SRL
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
4/21/2004
Days to Decision
156 days
Submission Type
Statement