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510(k) K880278

MALLEABLE PTFE COATED BRAIN SPATULAE by Downs Surgical , Ltd. — Product Code HAO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 11, 1988
Date Received
January 22, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrument, Surgical, Non-Powered
Device Class
Class I
Regulation Number
882.4535
Review Panel
NE
Submission Type

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  • K903748 — ISLAM STERNAL PUNCTURE NEEDLE, CAT # AF-594-00-V (October 31, 1990)
  • K903750 — ISLAM STERNAL PUNCTURE NEEDLE, CAT #AG-598-OO-E (October 31, 1990)
  • K900610 — SHEPPERD CANNULA STILLETTE & OBDURATOR SET (October 22, 1990)
  • K900609 — SHEPPERD STRAIGHT AND CURVED NEEDLES (October 22, 1990)
  • K900611 — SHEPPERD DILATATION TUBE SET (GS-501-20-H) (October 22, 1990)
  • K900613 — SHEPPERD SHELTER TUBE COMPLETE & DRILL (October 22, 1990)
  • K900608 — SHEPPERD LUMBAR DISCECTOMY SYSTEM (October 22, 1990)
  • K900615 — SHEPPERD NERVE ROOT RETRACTOR W/SUCTION & FIBRE (October 22, 1990)

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