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510(k) K802976

CARBONACRYL by Ipos Luneburg

K802976 is an FDA 510(k) premarket notification submitted by Ipos Luneburg for the device "CARBONACRYL". The FDA issued a decision of Substantially Equivalent on December 19, 1980. Ipos Luneburg has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 19, 1980
Date Received
November 21, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Other clearances by Ipos Luneburg

  • K834143 — NYLON COMPRESSION STUMP SHEATH (January 9, 1984)
  • K833868 — IPOS G.L.P. SYSTEM (November 28, 1983)
  • K831690 — IPOS ANTI-ADDUCTUS SHOE (June 24, 1983)
  • K802977 — IPOCARBON STRETCH STOCKINETTE (December 19, 1980)
  • K800749 — IPOCON 7 (July 28, 1980)
  • K800716 — ORTHOTIC LEG GAIT CORRECTOR DEVICE (May 2, 1980)
  • K800715 — OHC DYNAMIC CLUB FOOT BRACE (May 2, 1980)

FDA data resources