National Medical Healthcare Custom Orthopedic Kits and Trays
FDA 510(k) K971317 · National Healthcare Mfg. Corp.
510(k) numberK971317
Submission
- Device name
- National Medical Healthcare Custom Orthopedic Kits and Trays
- Applicant
- National Healthcare Mfg. Corp.
North Attleboro, MA, US - Received
- April 9, 1997
- Decision date
- May 8, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KDD – Kit, Surgical Instrument, Disposable
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4800
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code KDD
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K072814 | Convenience Kit for Single-Incision Laparoscopic Surgery and Other Advanced Laparoscopic…KDD · Traditional | Covidien | 04/16/2008SE |
| K011514 | Instruments for One Time Use - DisposableKDD · Traditional | Kencap , Ltd. | 08/13/2001SE |
| K960456 | Denver Paracentesis NEEDLE(60-1200) Denver Paracentesis Needle with Drainage…KDD · Traditional | Denver Biomaterials, Inc. | 04/01/1996SE |
| K936255 | Custom CV PackKDD · Traditional | Associated Medical | 03/31/1994SN |
| K932219 | Suture Set or Laceration Trays (Packs)KDD · Traditional | Associated Medical Products Co. | 07/09/1993SESK |
| K923176 | Surgical Instrument Kit, DisposableKDD · Traditional | Ulti-Med Intl., Inc. | 06/17/1993SE |
| K925905 | Kit, Surgical Instrument, DisposableKDD · Traditional | Kay Medical Concepts | 06/16/1993SESK |
| K924958 | Biopsy/Myelo/Arthro/Amniocent/Basic Skin Prep TrayKDD · Traditional | Medical Insights, Inc. | 06/07/1993SEKD |
| K925215 | Sterile Surgical Instrument TraysKDD · Traditional | American Healthcare Supply Co., Inc. | 06/01/1993SEKD |
| K924117 | Dexide Laparoscopic KitsKDD · Traditional | Dexide, Inc. | 03/23/1993SESK |
More from Dexide, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K972013 | National Medical Healthcare Custom OB/GYN Kits, Trays, or PacksKNA · Traditional | 08/26/1997SE |
| K971465 | National Medical Halthcare Custom Ophthalmic Kits or TraysHOY · Traditional | 06/04/1997SE |
| K962670 | NHMC Irrigation TrayLJH · Traditional | 08/14/1996SE |
| K962254 | NHMC Urethral Catheterization TrayFCM · Traditional | 07/29/1996SE |
| K960523 | NHMC Dressing TrayEFQ · Traditional | 04/04/1996SE |
| K960566 | NHMC Foley Catheterization TrayFCM · Traditional | 02/29/1996SE |
Questions and answers
When was National Medical Healthcare Custom Orthopedic Kits and Trays cleared by the FDA?
National Medical Healthcare Custom Orthopedic Kits and Trays (K971317) received a 510(k) decision of Substantially Equivalent on May 8, 1997, 29 days after the submission was received.
What is the product code of K971317?
The FDA product code is KDD – Kit, Surgical Instrument, Disposable, a Class I (low risk) device regulated under 21 CFR 878.4800.