Last synced on 18 April 2025 at 11:05 pm

SWISSPLUS IMPLANT SYSTEM, MODEL SPWB 8,10,12,14/OPH20/SMPR, SPB 8,10,12,14/OP3.5D/OPAR,OPB 8,10,12,14/OP2.3D/OP2.8D,

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K002188
510(k) Type
Traditional
Applicant
CORE-VENT CORP.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
10/30/2000
Days to Decision
102 days
Submission Type
Statement

SWISSPLUS IMPLANT SYSTEM, MODEL SPWB 8,10,12,14/OPH20/SMPR, SPB 8,10,12,14/OP3.5D/OPAR,OPB 8,10,12,14/OP2.3D/OP2.8D,

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K002188
510(k) Type
Traditional
Applicant
CORE-VENT CORP.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
10/30/2000
Days to Decision
102 days
Submission Type
Statement