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510(k) K841979

4MM CUP CURRETTE by Stainless Mfg., Inc. — Product Code HTF

K841979 is an FDA 510(k) premarket notification submitted by Stainless Mfg., Inc. for the device "4MM CUP CURRETTE". The FDA issued a decision of Substantially Equivalent on June 19, 1984. The device falls under product code HTF (Curette), a Class I device regulated under 21 CFR 878.4800. Stainless Mfg., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 19, 1984
Date Received
May 14, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Curette
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
Submission Type

Other clearances by Stainless Mfg., Inc.

  • K841980 — SIDE CUTTING SERRATED BLADE (August 15, 1984)
  • K841978 — LATERAL RELEASE KNIFE 5MM & 7MM (June 19, 1984)
  • K841981 — 4MM & 5MM FILE (June 19, 1984)
  • K841973 — BANANA KNIFE SERRATED (June 19, 1984)
  • K841970 — CAMELBACK HANDLE-K841969-LABELING (June 19, 1984)
  • K841971 — 2.5MM & 4MM PROBE K841969-LABELING (June 19, 1984)
  • K841969 — 6.5MM HEX HANDLE (June 19, 1984)
  • K841977 — 5MM DOUGLE EDGE RING CURETTE (June 19, 1984)
  • K841976 — HOOK KNIFE 4MM & 5MM (June 19, 1984)
  • K841975 — ROSETTE KNIFE 4MM (June 19, 1984)

Other clearances for product code HTF

  • K890252 — BONE CURETTE (January 27, 1989)
  • K870778 — ACROMED WALLIE-HEINIG CURETTES (March 9, 1987)

FDA data resources