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510(k) K812562

SURGICAL RETRACTOR & ELASTIC STAYS, DISP by Humboldt Products — Product Code GDG

K812562 is an FDA 510(k) premarket notification submitted by Humboldt Products for the device "SURGICAL RETRACTOR & ELASTIC STAYS, DISP". The FDA issued a decision of Substantially Equivalent on October 2, 1981. The device falls under product code GDG (Hook, Surgical, General & Plastic Surgery), a Class I device regulated under 21 CFR 878.4800. Humboldt Products has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 2, 1981
Date Received
September 8, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Hook, Surgical, General & Plastic Surgery
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
Submission Type

Other clearances by Humboldt Products

  • K832540 — DRUMTO STAPES PROSTHESIS (January 3, 1984)
  • K823483 — STAINLESS STEEL PISTONS (December 9, 1982)
  • K813616 — TEKNA MED MYRINGOTOMY DISPOS-OTO KIT (January 22, 1982)
  • K802587 — OTOLOGICAL VENTILATION TUBES (November 12, 1980)

Other clearances for product code GDG

  • K900069 — MODIFIED PGL ABSORBABLE STAPLE* (April 16, 1990)
  • K891898 — SKIN HOOKS, VARIOUS TYPES (April 12, 1989)
  • K864425 — RAYLOR(TM) DISSECTING HOOK (December 12, 1986)
  • K843136 — BRIMFIELD CANNULATED GRASPING HOOKS (September 25, 1984)
  • K841010 — SURGICAL HOOKS, VARIOUS (May 1, 1984)
  • K791120 — MIDDLE EAR PICKS, HOOKS CURETTES, (July 10, 1979)
  • K780289 — NERVE APPROXIMATER (June 14, 1978)
  • K771187 — DERMAHOOK #382-805 (July 11, 1977)
  • K771190 — ABRAMSON TRACHEA HOOK & RETRACTOR (July 11, 1977)

FDA data resources