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510(k) K181393

Empty Eva Bag, models FVM0134BP, FVM0135BP, FVM0136BP, FVM0137BP, FVM0138BP, FVM0139BP, FVM0140BP, FVM0141BP by Valmed S.R.L. — Product Code KPE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 15, 2019
Date Received
May 29, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Container, I.V.
Device Class
Class II
Regulation Number
880.5025
Review Panel
HO
Submission Type

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  • K010754 — NURSE'S ASSISTANT O.R. CONTROL SYSTEM (August 15, 2001)
  • K010716 — VAL LUX 600 SURGICAL LIGHT (PLUS AND RS), MODEL ML600/S: SINGLE LIGHT HEAD, ML60 (May 30, 2001)
  • K925336 — VALU-PLUS PAD (February 12, 1993)

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