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510(k) K935621

CUSTOM ENT PACKS by Associated Medical — Product Code LRP

K935621 is an FDA 510(k) premarket notification submitted by Associated Medical for the device "CUSTOM ENT PACKS". The FDA issued a decision of Substantially Equivalent on March 30, 1994. The device falls under product code LRP (Tray, Surgical), a Class I device regulated under 21 CFR 878.4800. Associated Medical has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 30, 1994
Date Received
November 22, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tray, Surgical
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
Submission Type

Other clearances by Associated Medical

  • K936255 — CUSTOM CV PACK (March 31, 1994)
  • K935622 — CUSTOM PLASTIC PACKS (February 7, 1994)

Other clearances for product code LRP

  • K963723 — LACERATION TRAY (November 27, 1996)
  • K951811 — OSTEOTECH MUSCULOSKELETAL TISSUE RECOVERY PACK (May 31, 1995)
  • K940239 — EYE TRAY (June 28, 1994)
  • K940646 — ORTHOPEDIC TRAY PRODUCT LINE (March 11, 1994)
  • K940444 — GENERAL SURGERY TRAY (March 7, 1994)
  • K922126 — HOSPITAL KIT ENT 1125 (January 21, 1993)
  • K912105 — EYE TRAY (August 29, 1991)
  • K903963 — KITS AND TRAYS FOR ONE TIME USE ONLY (July 29, 1991)
  • K903962 — INSTRUMENTS FOR ONE TIME USE/ DISPOSABLE (July 29, 1991)
  • K905462 — PROCEDURE TRAY/FOR VARIOUS OPHTHALMIC PROCEDURES (February 6, 1991)

FDA data resources