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510(k) K922126

HOSPITAL KIT ENT 1125 by Savoy Medical Supply Co., Inc. — Product Code LRP

K922126 is an FDA 510(k) premarket notification submitted by Savoy Medical Supply Co., Inc. for the device "HOSPITAL KIT ENT 1125". The FDA issued a decision of Substantially Equivalent on January 21, 1993. The device falls under product code LRP (Tray, Surgical), a Class I device regulated under 21 CFR 878.4800. Savoy Medical Supply Co., Inc. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 21, 1993
Date Received
May 6, 1992
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 Savoy Medical Supply Co., Inc.

  • K922133 — HOSPITAL KIT SV 105 (June 7, 1993)
  • K922130 — HOSPITAL KIT DK 117 (May 24, 1993)
  • K922127 — HOSPITAL KIT GP 103 (March 29, 1993)
  • K923281 — SV 100200 - SINGLE USE ONLY - STERILE HOSPITAL KIT (March 26, 1993)
  • K922128 — HOSPITAL KIT EP 104 (March 23, 1993)
  • K923283 — SUP 5415 SINGLE USE ONLY STERILE HOSPITAL KIT (January 4, 1993)

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)
  • K935621 — CUSTOM ENT PACKS (March 30, 1994)
  • K940646 — ORTHOPEDIC TRAY PRODUCT LINE (March 11, 1994)
  • K940444 — GENERAL SURGERY TRAY (March 7, 1994)
  • 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