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510(k) K040779

RESTORE WOUND CLEANSER by Hollister, Inc. — Product Code KMF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 17, 2004
Date Received
March 26, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bandage, Liquid
Device Class
Class I
Regulation Number
880.5090
Review Panel
SU
Submission Type

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  • K050483 — EVADRI BLADDER CONTROL SYSTEMS (April 12, 2005)
  • K013612 — INCARE PELVIC FLOOR THERAPY SYSTEM (March 19, 2002)
  • K013653 — INCARE PRESSURE BIOFEEDBACK VAGINAL PRESSURE PROBE AND ANAL PRESSURE PROBE (March 5, 2002)
  • K013483 — INCARE ADVANCE; INTERMITTENT CATHETER, PLUS INTERMITTENT CATHETER, PLUS KIT (January 14, 2002)
  • K013345 — INCARE INTERMITTENT CATHETER (January 7, 2002)
  • K013141 — MICROGYN PLUS STIMULATION DEVICE (December 19, 2001)

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  • K120059 — LIQUID BANDAGE (May 17, 2012)
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