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510(k) K841513

SCANLAN ATRAUM INSTRUMENT JAW COVER by Scanlan Intl., Inc.

K841513 is an FDA 510(k) premarket notification submitted by Scanlan Intl., Inc. for the device "SCANLAN ATRAUM INSTRUMENT JAW COVER". The FDA issued a decision of Substantially Equivalent on July 6, 1984. Scanlan Intl., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 6, 1984
Date Received
April 12, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Other clearances by Scanlan Intl., Inc.

  • K960372 — SCANLAN HEIFETZ ANEURYSM ELGILOY CLIP SYSTEM (April 26, 1996)
  • K945474 — SCANLAN(R) THORACOSCOPIC SCISSORS, CLAMP, FORCEPS, NEEDLE HOLDER (December 5, 1994)
  • K911184 — SCANLAN/TAHERI VALVULOTOME (February 18, 1992)
  • K864919 — SCANLAN (TM) VEIN/GRAFT HOLDER (January 12, 1987)
  • K864920 — SCANLAN (TM) INSTRUMENT TRAY (January 12, 1987)
  • K851825 — SCANLAN TUNNELER, SHEATH & TIP (July 12, 1985)
  • K841521 — SCANLAN ENDARSECTOR (August 3, 1984)
  • K841085 — SCANLAN COLORMARK SKIN MARKER (June 11, 1984)
  • K841515 — SCANLAN VASCU-STATT II (June 5, 1984)
  • K841514 — SCANLAN VASCU-STATT II APPROXIMATOR (June 5, 1984)

FDA data resources