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510(k) K801072

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

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

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  • 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)