Paraplast Extra Tissue Embedding Med.
FDA 510(k) K842053 · Sherwood Medical Co.
510(k) numberK842053
Submission
- Device name
- Paraplast Extra Tissue Embedding Med.
- Applicant
- Sherwood Medical Co.
Mchenry, IL, US - Received
- May 22, 1984
- Decision date
- June 26, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Other 510(k)s with product code KEO
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K893772 | Tissue Embedding MediumKEO · Traditional | Stephens Scientific | 06/22/1989SE |
| K862223 | Micro Thin* ParaffinKEO · Traditional | Richard-Allan Medical Ind., Inc. | 06/17/1986SE |
| K862141 | Histology ParaffinKEO · Traditional | Erie Scientific Co. | 06/13/1986SE |
| K861270 | Blue Ribbon Paraffin Infiltration/Embedding Med.KEO · Traditional | Surgipath Medical Industries, Inc. | 04/11/1986SE |
| K833071 | Technicon ParacutKEO · Traditional | Technicon Instruments Corp. | 10/14/1983SE |
| K831580 | Paraffin Infiltration MediumKEO · Traditional | Surgipath Medical Industries, Inc. | 06/17/1983SE |
| K812191 | Vaspar SealentKEO · Traditional | American Scientific Products | 08/31/1981SE |
| K810568 | Paraffin Embedding MediumKEO · Traditional | Surgipath Medical Industries, Inc. | 03/17/1981SE |
| K803241 | Histological Embedding MediaKEO · Traditional | Miles Laboratories, Inc. | 01/28/1981SE |
| K760602 | Sorvall Embedding MediumKEO · Traditional | E.I. Dupont DE Nemours & Co., Inc. | 09/21/1976SE |
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| 510(k) | Device | Decision |
|---|---|---|
| K981365 | Mahurkar 13.5 FR Cuffed Catheter with Curved ExtensionsMSD · Traditional | 11/25/1998SE |
| K960982 | Monoject Blunt I.V. Access Cannula/Monoject Hypodermic Syringe with Blunt I.V. Access…FMI · Traditional | 12/23/1996SE |
| K962880 | Sensi-Touch Combo Spinal/Epidural Regional Anesthesia Delivery SystemCAZ · Traditional | 12/09/1996SESK |
| K960574 | Argyle Turkel Neonatal/Pediatric Thoracic Catheter Insertion Tray and Thoracic Catheter…FHO · Traditional | 08/05/1996SE |
| K960677 | Kangaroo Jejunal Feeding SystemKNT · Traditional | 05/13/1996SE |
| K960632 | Kangaroo Feeding Tube Placment StyletKNT · Traditional | 05/09/1996SE |
| K955831 | Argyle Aspr-Care Closed Suction SystemBSY · Traditional | 03/28/1996SE |
| K954429 | Kangaroo Entristar Skin-Level Gastrostomy KitKNT · Traditional | 03/08/1996SESK |
| K954525 | Sensi-Touch Epidural Anesthesia FilterBXN · Traditional | 01/19/1996SE |
| K950201 | Argyle(R) Hydrophilic Coated Thoracic CatheterJOL · Traditional | 12/15/1995SE |
Questions and answers
When was Paraplast Extra Tissue Embedding Med. cleared by the FDA?
Paraplast Extra Tissue Embedding Med. (K842053) received a 510(k) decision of Substantially Equivalent on June 26, 1984, 35 days after the submission was received.
What is the product code of K842053?
The FDA product code is KEO – Formulations, Paraffin, All, a Class I (low risk) device regulated under 21 CFR 864.4010.