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510(k) K930507

CUSTOM ORTHOPAEDIC TRAYS (PACKS) by Associated Medical Products Co. — Product Code HTS

K930507 is an FDA 510(k) premarket notification submitted by Associated Medical Products Co. for the device "CUSTOM ORTHOPAEDIC TRAYS (PACKS)". The FDA issued a decision of Substantially Equivalent on February 22, 1994. The device falls under product code HTS (Knife, Orthopedic), a Class I device regulated under 21 CFR 888.4540. Associated Medical Products Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 22, 1994
Date Received
February 1, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Knife, Orthopedic
Device Class
Class I
Regulation Number
888.4540
Review Panel
OR
Submission Type

Other clearances by Associated Medical Products Co.

  • K932221 — NEUROLOGICAL OR CRANI TRAYS (PACKS) (March 19, 1997)
  • K932216 — C-SECTION, LABOR & DELIVERY TRAYS (PACKS) (April 19, 1994)
  • K932217 — MAJOR, MINOR, BASIN TRAYS (PACKS) (November 15, 1993)
  • K932220 — LAP CHOLY TRAYS (PACKS) (September 27, 1993)
  • K932218 — CARDIAC CATH OR ANGIOGRAPHIC TRAYS (August 27, 1993)
  • K932219 — SUTURE SET OR LACERATION TRAYS (PACKS) (July 9, 1993)
  • K842983 — AMPCO OPTHALMIC TRAY (May 22, 1985)
  • K843114 — AMPCO PROCEDURE TRAYS / PACKS (August 8, 1984)
  • K823839 — AMPCO KIDNEY DIALYSIS TRAY (March 29, 1983)
  • K821579 — SKIN SCRUB-TRAY (July 21, 1982)

Other clearances for product code HTS

  • K933921 — ACUFLEX DISPOSABLE KNIVES (January 26, 1994)
  • K882525 — SPINAL MICROKNIFE (September 22, 1988)
  • K873714 — BANANA KNIFE, DISPOSABLE #TM-1612 (November 2, 1987)
  • K873713 — TRIANGULAR KNIFE, DISPOSABLE #TM-1611 (November 2, 1987)
  • K873711 — RETROGRADE KNIFE, DISPOSABLE #TM-1613 (November 2, 1987)
  • K873712 — STANDARD KNIFE, DISPOSABLE #TM-1610 (October 15, 1987)
  • K842820 — ARTHROSCOPY KNIVES (August 14, 1984)
  • K771851 — ARTHROSCOPE OPERATIVE KNIFE SET (October 27, 1977)

FDA data resources