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510(k) K102512

RMS SUBCUTANEOUS NEEDLE SET by Repro-Med Systems, Inc. — Product Code FPA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 20, 2011
Date Received
September 1, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Set, Administration, Intravascular
Device Class
Class II
Regulation Number
880.5440
Review Panel
HO
Submission Type

Other clearances by Repro-Med Systems, Inc.

  • K981506 — RESTORE VACUUM ERECTION DEVICE, CONFIDE VACUUM ERECTION DEVICE, PEP (PENILE EREC (June 25, 1998)
  • K933652 — FREEDOM 60 SYRINGE INFUSION PUMP SYSTEM WITH SYRINGE SET & TUBING (May 18, 1994)
  • K894299 — REPRO-MED EMERGENCY AIRWAY VACUUM SYSTEM (September 22, 1989)
  • K892529 — REPRO-MED NEONATE ASPIRATION SYSTEM (June 12, 1989)
  • K844401 — REPRO-MED SYSTEMS INFUSION DEVICE (March 12, 1985)

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