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SIGMA ELITE

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K942545
510(k) Type
Traditional
Applicant
PENLON LTD.
Country
United Kingdom
FDA Decision
Substantially Equivalent
Decision Date
2/3/1995
Days to Decision
248 days
Submission Type
Summary

SIGMA ELITE

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K942545
510(k) Type
Traditional
Applicant
PENLON LTD.
Country
United Kingdom
FDA Decision
Substantially Equivalent
Decision Date
2/3/1995
Days to Decision
248 days
Submission Type
Summary