Last synced on 10 January 2025 at 11:05 pm

PKS PLASMA MORCELLATOR, MODELS 962000PK, 3620PK

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K080093
510(k) Type
Traditional
Applicant
GYRUS ACMI, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
5/2/2008
Days to Decision
109 days
Submission Type
Summary

PKS PLASMA MORCELLATOR, MODELS 962000PK, 3620PK

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K080093
510(k) Type
Traditional
Applicant
GYRUS ACMI, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
5/2/2008
Days to Decision
109 days
Submission Type
Summary