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510(k) K780991

PARALLEL BLADE MARKER by Nestor Engineering Associates, Inc. — Product Code EMF

K780991 is an FDA 510(k) premarket notification submitted by Nestor Engineering Associates, Inc. for the device "PARALLEL BLADE MARKER". The FDA issued a decision of Substantially Equivalent on October 3, 1978. The device falls under product code EMF (Knife, Surgical), a Class I device regulated under 21 CFR 878.4800. Nestor Engineering Associates, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 3, 1978
Date Received
June 14, 1978
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Knife, Surgical
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
Submission Type

Other clearances by Nestor Engineering Associates, Inc.

  • K780988 — DEVIN-NESTOR PNEUMATIC TOURNIQUET (October 3, 1978)
  • K780989 — DEVIN-NESTOR SQUARE KNIFE (October 3, 1978)
  • K780990 — STAINLESS STEEL TEMPLATE (October 3, 1978)
  • K780992 — MILLARD MOUTH GAG (August 17, 1978)

Other clearances for product code EMF

  • K080133 — MOUNTABLE ENDOSCOPIC BLADE (March 13, 2008)
  • K982142 — MOUNTABLE ENDOSCOPIC KNIFE (December 30, 1998)
  • K890217 — MICROSURGICAL KNIVES (January 27, 1989)
  • K890215 — MICROSURGICAL SCARIFIER (January 27, 1989)
  • K890214 — MICROSURGERY RAZOR BLADE HOLDER (January 27, 1989)
  • K880094 — VAN-TEC ENDOPYELOTOMY KNIFE (February 29, 1988)
  • K863752 — VALTRAC (BAR) REMOVER DEVICE (October 24, 1986)
  • K863549 — REUSABLE/DISPOSABLE AUTOPSY KNIFE SET (September 30, 1986)
  • K861947 — SURGICAL KNIFE (June 6, 1986)
  • K854891 — KNIFE (May 2, 1986)

FDA data resources