Lacerattion Tray

FDA 510(k) K920763 · Sterile Concepts, Inc.

Unknown

510(k) numberK920763

Submission

Device name
Lacerattion Tray
Applicant
Sterile Concepts, Inc.
Richmond, VA, US
Received
February 19, 1992
Decision date
September 28, 1992
Decision
Unknown (SESK)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
KDD – Kit, Surgical Instrument, Disposable
Device class
Class I (low risk)
Regulation
21 CFR 878.4800
Specialty
General, Plastic Surgery

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K072814Convenience Kit for Single-Incision Laparoscopic Surgery and Other Advanced Laparoscopic…KDD · Traditional Covidien04/16/2008SE
K011514Instruments for One Time Use - DisposableKDD · Traditional Kencap , Ltd.08/13/2001SE
K971317National Medical Healthcare Custom Orthopedic Kits and TraysKDD · Traditional National Healthcare Mfg. Corp.05/08/1997SE
K960456Denver Paracentesis NEEDLE(60-1200) Denver Paracentesis Needle with Drainage…KDD · Traditional Denver Biomaterials, Inc.04/01/1996SE
K936255Custom CV PackKDD · Traditional Associated Medical03/31/1994SN
K932219Suture Set or Laceration Trays (Packs)KDD · Traditional Associated Medical Products Co.07/09/1993SESK
K923176Surgical Instrument Kit, DisposableKDD · Traditional Ulti-Med Intl., Inc.06/17/1993SE
K925905Kit, Surgical Instrument, DisposableKDD · Traditional Kay Medical Concepts06/16/1993SESK
K924958Biopsy/Myelo/Arthro/Amniocent/Basic Skin Prep TrayKDD · Traditional Medical Insights, Inc.06/07/1993SEKD
K925215Sterile Surgical Instrument TraysKDD · Traditional American Healthcare Supply Co., Inc.06/01/1993SEKD

More from American Healthcare Supply Co., Inc.

510(k)DeviceDecision
K951231Orthopedic PacksGAN · Traditional 12/01/1995SE
K951081OB/GYN PacksKNA · Traditional 11/13/1995SE
K952539Radiology PacksLRO · Traditional 07/14/1995SE
K951478General and Plastic Surgery PacksLRO · Traditional 06/13/1995SE
K944139Dental Hygiene TrayLYY · Traditional 12/15/1994SE
K943047IV Start KitsKMK · Traditional 09/14/1994SE
K943090Suture Removal TraysFRG · Traditional 08/22/1994SEKD
K940864Dentist with Assistant PackEIA · Traditional 08/02/1994SE
K943046Skin Staple Removal TraysMCZ · Traditional 07/29/1994SESK

Questions and answers

When was Lacerattion Tray cleared by the FDA?

Lacerattion Tray (K920763) received a 510(k) decision of Unknown on September 28, 1992, 222 days after the submission was received.

What is the product code of K920763?

The FDA product code is KDD – Kit, Surgical Instrument, Disposable, a Class I (low risk) device regulated under 21 CFR 878.4800.