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510(k) K862576

PS2 BRAND FACIAL SYMMETRY GUIDE (LEE DESIGN) by Professional Services For Surgeons, Ltd. — Product Code FTY

K862576 is an FDA 510(k) premarket notification submitted by Professional Services For Surgeons, Ltd. for the device "PS2 BRAND FACIAL SYMMETRY GUIDE (LEE DESIGN)". The FDA issued a decision of Substantially Equivalent on July 15, 1986. The device falls under product code FTY (Tape, Measuring, Rulers And Calipers), a Class I device regulated under 21 CFR 878.4800. Professional Services For Surgeons, Ltd. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 15, 1986
Date Received
July 7, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tape, Measuring, Rulers And Calipers
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
Submission Type

Other clearances by Professional Services For Surgeons, Ltd.

  • K860912 — PS2 BRAND MAMMAPLASTY (March 24, 1986)

Other clearances for product code FTY

  • K160501 — Noxilizer Surgical Ruler (May 26, 2016)
  • K951064 — DISPOSABLE WOUND MEASURE GUIDE, PLASTIC, PROTECTOR, WOUND, PLASTIC (May 19, 1995)
  • K934930 — OLYMPIC AUTO-LENGTH (December 29, 1993)
  • K932112 — OLYMPIC INFA-LENGTH (July 22, 1993)
  • K883485 — STRYKER PRESSURE MONITOR SYSTEM (September 13, 1988)
  • K880441 — PEDIATRIC AIRWAY MEASUREMENT SYSTEM & P.A.M.S. (February 18, 1988)
  • K874352 — TUMORIMETER (November 23, 1987)
  • K873470 — TEMPLATE (September 8, 1987)
  • K872319 — LN 100 BREAST MARKER (August 11, 1987)
  • K863409 — KUNDIN WOUND GAUGE (September 29, 1986)

FDA data resources