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510(k) K801072

STRAITH NASAL SPLINT by Surgical Technology Laboratories, Inc. — Product Code FYI

K801072 is an FDA 510(k) premarket notification submitted by Surgical Technology Laboratories, Inc. for the device "STRAITH NASAL SPLINT". The FDA issued a decision of Substantially Equivalent on June 17, 1980. The device falls under product code FYI (Appliance, Facial Fracture, External), a Class I device regulated under 21 CFR 878.3250. Surgical Technology Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 17, 1980
Date Received
May 6, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Appliance, Facial Fracture, External
Device Class
Class I
Regulation Number
878.3250
Review Panel
SU
Submission Type

Other clearances by Surgical Technology Laboratories, Inc.

  • K170582 — Saf-T-Vac Smoke and Fluid Evacuator (April 14, 2017)
  • K021889 — SURGIFORM AUGMENTATION MATERIAL (S.F.A.M.) (October 16, 2002)
  • K983755 — NASAL DORSAL SERIES (November 20, 1998)
  • K983756 — SURGIFORM ANATOMICAL MALAR (November 20, 1998)
  • K983754 — STANDARD CHIN (November 20, 1998)
  • K964443 — SURGIFORM ANATOMICAL MALAR (December 20, 1996)
  • K840835 — STRAITH DRAIN INSERTER (April 23, 1984)
  • K831078 — STRAITH ORAL AIRWAY (June 24, 1983)
  • K801074 — STRAITH NASAL IMPLANT (June 17, 1980)
  • K801075 — STRAITH CHISEL FORCEPS (May 20, 1980)

Other clearances for product code FYI

  • K871073 — OMEGA BIVALVE NASAL SPLINTS (May 11, 1987)
  • K821178 — ETHICON EXTERNAL FIXATION WIRE (June 11, 1983)
  • K792106 — CONPHAR O.R. HEAD COVER-STERILE (November 5, 1979)

FDA data resources