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510(k) K251648

GPS Advanced; GPS Advanced Cannula by Prosidyan, Inc. — Product Code FMF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 24, 2025
Date Received
May 29, 2025
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Syringe, Piston
Device Class
Class II
Regulation Number
880.5860
Review Panel
HO
Submission Type

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  • K143533 — FIBERGRAFT BG PUTTY BONE GRAFT SUBSTITUTE (March 25, 2015)
  • K141956 — FIBERGRAFT BG MORSELS (August 13, 2014)

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