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510(k) K874966

TUNING FORKS by Solway, Inc. — Product Code GWX

K874966 is an FDA 510(k) premarket notification submitted by Solway, Inc. for the device "TUNING FORKS". The FDA issued a decision of Substantially Equivalent on January 4, 1988. The device falls under product code GWX (Fork, Tuning), a Class I device regulated under 21 CFR 882.1525. Solway, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 4, 1988
Date Received
December 2, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Fork, Tuning
Device Class
Class I
Regulation Number
882.1525
Review Panel
NE
Submission Type

Other clearances by Solway, Inc.

  • K874960 — CARDIOVASCULAR SURGICAL INSTRUMENTS (February 5, 1988)
  • K874962 — FORCEPS CLIPRACK VENTRICULAR CANNULA SAWS SPATULAS (February 2, 1988)
  • K874956 — SELF-RETAINING RETRACTOR FOR NEUROSURGERY (January 28, 1988)
  • K874964 — DENTAL HAND INSTRUMENTS (January 27, 1988)
  • K875043 — RONGEUR (NEUROSURGICAL INSTRUMENTS) (January 22, 1988)
  • K874959 — VASCULAR CLAMP (December 30, 1987)
  • K874965 — MANUAL SURGICAL INSTRUMENTS FOR GENERAL USE (December 30, 1987)
  • K874961 — BONE CUTTING INSTRUMENTS & ACCESSORIES (December 30, 1987)
  • K874950 — MICROSURGICAL INSTRUMENTS (December 30, 1987)
  • K874954 — MANUAL RONGEUR (December 30, 1987)

Other clearances for product code GWX

  • K813304 — CONPHAR, TUNING FORKS (December 10, 1981)
  • K761132 — TUNING FORK (December 2, 1976)
  • K760303 — FORK, TUNING BK-7519 (September 8, 1976)

FDA data resources