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SD-610M(ALSO KNOWN AS STANDARD TENS, SD-609M,SD-611M, GLC-I STANDARD)

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K963729
510(k) Type
Traditional
Applicant
SKYLARK DEVICE CO., LTD.
Country
Taiwan
FDA Decision
Substantially Equivalent
Decision Date
2/13/1997
Days to Decision
150 days
Submission Type
Statement

SD-610M(ALSO KNOWN AS STANDARD TENS, SD-609M,SD-611M, GLC-I STANDARD)

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K963729
510(k) Type
Traditional
Applicant
SKYLARK DEVICE CO., LTD.
Country
Taiwan
FDA Decision
Substantially Equivalent
Decision Date
2/13/1997
Days to Decision
150 days
Submission Type
Statement