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510(k) K101424

PHARMACARIBE INHALED SALINE SOLUTIONS by Pharmacaribe — Product Code CAF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 17, 2010
Date Received
May 20, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Nebulizer (Direct Patient Interface)
Device Class
Class II
Regulation Number
868.5630
Review Panel
AN
Submission Type

Other clearances by Pharmacaribe

  • K130091 — PULMOSAL (March 13, 2013)
  • K101532 — NESSI OTC SPACER (September 1, 2010)
  • K091862 — NESSI SPACER (November 20, 2009)

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