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510(k) K914759

BLOOM TRANSPARENT STENCIL by Freckles Publications, Inc. — Product Code FZZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 21, 1992
Date Received
October 22, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Marker, Skin
Device Class
Class I
Regulation Number
878.4660
Review Panel
SU
Submission Type

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  • K904559 — QUALTEX SKIN MARKER (December 13, 1990)
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  • K864371 — SURGICAL SKIN MARKER (November 17, 1986)
  • K863280 — DERMAMARKER (September 9, 1986)
  • K861772 — LASER SKIN MARKER AND MASK WHITE LOTION (May 21, 1986)
  • K844865 — SECURLINE SURGICAL SKIN MARKER 1000 (January 14, 1985)