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510(k) K892364

KALTOSTAT(TM) WOUND DRESSING by Calgon Vestal Div. — Product Code FRO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 23, 1989
Date Received
April 6, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dressing, Wound, Drug
Device Class
Class U
Regulation Number
Review Panel
SU
Submission Type

Other clearances by Calgon Vestal Div.

  • K944494 — ALSA-KLENZ (October 19, 1994)
  • K944033 — BILL EVANS-KLENZ (October 7, 1994)
  • K942270 — SAF-GEL HYDRATING DERMAL WOUND DRESSING (August 4, 1994)
  • K931477 — AMERSE (June 17, 1994)
  • K931816 — VESTA-SYDE(R) INTERIM INSTR DECONTAMINATION SYSTEM (May 26, 1994)
  • K931342 — LPH (May 26, 1994)
  • K941163 — MON-KLENZ (May 18, 1994)
  • K931573 — VESPHENE II (May 16, 1994)
  • K932277 — LONZA FORMULATION R-82 (May 12, 1994)
  • K931599 — HYDRASORB STERILE DRESSING (July 8, 1993)

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