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510(k) K840820

SECURLINE SURGICAL SKIN MARKER 1000 by Precision Dynamics Corp. — Product Code FZZ

K840820 is an FDA 510(k) premarket notification submitted by Precision Dynamics Corp. for the device "SECURLINE SURGICAL SKIN MARKER 1000". The FDA issued a decision of Substantially Equivalent on April 25, 1984. The device falls under product code FZZ (Marker, Skin), a Class I device regulated under 21 CFR 878.4660. Precision Dynamics Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 25, 1984
Date Received
February 24, 1984
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

Other clearances by Precision Dynamics Corp.

  • K020718 — SECURLINE UMBILICAL CORD CLAMP #3505 STERILE #3515 NON-STERILE (June 3, 2002)
  • K994353 — SECURELINE DISPOSABLE FETAL MONITORING STRAPS #3860 AND #3565 (March 22, 2000)
  • K994263 — SECURLINE UMBILICAL CORD CLAMP CLIPPER #3540 (January 24, 2000)
  • K990737 — 'ECURLINE UMBILICAL CORD CLAMP #3500 (April 6, 1999)
  • K884357 — PRECISION BIOPORT COLLECTION & TRANSPORT SYSTEM (November 1, 1988)
  • K882580 — MECHANICAL CHANGE IN IN-VITRO MICRO DEVICE (July 8, 1988)
  • K874665 — SECURLINE FINE NEEDLE ASPIRATION BIOPSY TRAY (January 20, 1988)
  • K873369 — SECURLINE FRANSEENE NEEDLE (October 20, 1987)
  • K872507 — PRECISION CULTURE C.A.T.S. COLLECT/TRANS HSV I/II (July 9, 1987)
  • K863164 — AGAR REDUCTION IN FORMULA FOR PDC 110 & 310 MEDIA (August 27, 1986)

Other clearances for product code FZZ

  • K042555 — SURGICHIP TAG SURGICAL MARKER (November 9, 2004)
  • K915066 — DISPOSABLE SKIN MARKER (May 14, 1992)
  • K914759 — BLOOM TRANSPARENT STENCIL (April 21, 1992)
  • K912730 — ROCKET SURGICAL SKIN MARKING PEN (November 7, 1991)
  • K905143 — SKIN MARKER (February 6, 1991)
  • K904559 — QUALTEX SKIN MARKER (December 13, 1990)
  • K896792 — SURGICAL SKIN MARKER (December 27, 1989)
  • K864371 — SURGICAL SKIN MARKER (November 17, 1986)
  • K863280 — DERMAMARKER (September 9, 1986)
  • K861772 — LASER SKIN MARKER AND MASK WHITE LOTION (May 21, 1986)

FDA data resources