Micro Thin* Paraffin
FDA 510(k) K862223 · Richard-Allan Medical Ind., Inc.
510(k) numberK862223
Submission
- Device name
- Micro Thin* Paraffin
- Applicant
- Richard-Allan Medical Ind., Inc.
Richland, MI, US - Received
- June 11, 1986
- Decision date
- June 17, 1986
- 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 |
| 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 |
| K842053 | Paraplast Extra Tissue Embedding Med.KEO · Traditional | Sherwood Medical Co. | 06/26/1984SE |
| 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 |
More from E.I. Dupont DE Nemours & Co., Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K931879 | Reflex HTRGCJ · Traditional | 03/24/1994SE |
| K924200 | Reflex(R) EscKNF · Traditional | 02/22/1994SE |
| K926297 | Reflex EsiGEI · Traditional | 10/15/1993SE |
| K924761 | Sterile Endoscopic Dispos Trocars W/Safe ShieldGCJ · Traditional | 04/20/1993SE |
| K900566 | Richard-Allan Vessel LoopsKDC · Traditional | 05/03/1990SE |
| K896262 | Titanium Ligating ClipsHBT · Traditional | 01/02/1990SE |
| K890314 | Protector (Surgical Instrument)MMK · Traditional | 02/27/1989SE |
| K873309 | Reflex(Tm) Ca-T Clip ApplierFZP · Traditional | 11/27/1987SE |
| K862404 | Reflex(Tm) Clip ApplierFZP · Traditional | 07/23/1986SE |
| K861890 | 100%, 95%, 80% & 70% Dehydrant Custom Blend No. 2PPM · Traditional | 06/03/1986SE |
Questions and answers
When was Micro Thin* Paraffin cleared by the FDA?
Micro Thin* Paraffin (K862223) received a 510(k) decision of Substantially Equivalent on June 17, 1986, 6 days after the submission was received.
What is the product code of K862223?
The FDA product code is KEO – Formulations, Paraffin, All, a Class I (low risk) device regulated under 21 CFR 864.4010.