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YP 45/15-BP; YP 53/15-BP; YP 60/15-BP

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K993139
510(k) Type
Traditional
Applicant
BIOTRONIK, INC.
Country
United States
FDA Decision
Substantially Equivalent - Subject to Tracking Regulation
Decision Date
12/17/1999
Days to Decision
88 days

YP 45/15-BP; YP 53/15-BP; YP 60/15-BP

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K993139
510(k) Type
Traditional
Applicant
BIOTRONIK, INC.
Country
United States
FDA Decision
Substantially Equivalent - Subject to Tracking Regulation
Decision Date
12/17/1999
Days to Decision
88 days