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510(k) K162284

Puritan Fecal Opti-Swab Collection and Transport System by Puritan Medical Products, LLC — Product Code JSM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 4, 2016
Date Received
August 15, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Culture Media, Non-Propagating Transport
Device Class
Class I
Regulation Number
866.2390
Review Panel
MI
Submission Type

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  • K120846 — TRANSPORT CULTURE MEDIUM DEVICE (June 8, 2012)
  • K113249 — TRANSPORT CULTURE MEDIUM DEVICE (March 1, 2012)

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