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EXTRA TENS (RI-2500) NEO TENS (RI-2000E)

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K963507
510(k) Type
Traditional
Applicant
COMTEK INTL., CORP.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
3/19/1997
Days to Decision
197 days
Submission Type
Statement

EXTRA TENS (RI-2500) NEO TENS (RI-2000E)

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K963507
510(k) Type
Traditional
Applicant
COMTEK INTL., CORP.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
3/19/1997
Days to Decision
197 days
Submission Type
Statement