Pediwet=Guaze Impregnated with Petrol
FDA 510(k) K802007 · Pollak (Intl.), Ltd.
510(k) numberK802007
Submission
- Device name
- Pediwet=Guaze Impregnated with Petrol
- Applicant
- Pollak (Intl.), Ltd.
Walker, MI, US - Received
- August 20, 1980
- Decision date
- September 26, 1980
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- FRQ – Tube, Levine
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5980
- Specialty
- Gastroenterology, Urology
Other 510(k)s with product code FRQ
More from Icn Pharmaceuticals, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K000227 | UmbicutHFW · Traditional | 04/27/2000SE |
| K810049 | Pedicat*KMJ · Traditional | 04/21/1981SE |
| K810050 | Vecafix*KGX · Traditional | 03/26/1981SE |
| K802011 | Infussion Alarm System I.A.S. CAT.#1118FLN · Traditional | 10/31/1980SE |
| K802009 | Flowclamp CAT.#1011 & 1012FKK · Traditional | 10/31/1980SE |
| K802017 | Dressing Change Set CAT.#910-930KDD · Traditional | 10/10/1980SE |
| K802022 | Sterile Guaze Swabs CAT.#301-420EFQ · Traditional | 09/16/1980SE |
| K802021 | Pediband CAT.#195-197NAD · Traditional | 09/16/1980SE |
| K802019 | Suture Removal Set CAT.#906KDD · Traditional | 09/16/1980SE |
| K802016 | Eye Applicators CAT.#980-983KXF · Traditional | 09/16/1980SE |
Questions and answers
When was Pediwet=Guaze Impregnated with Petrol cleared by the FDA?
Pediwet=Guaze Impregnated with Petrol (K802007) received a 510(k) decision of Substantially Equivalent on September 26, 1980, 37 days after the submission was received.
What is the product code of K802007?
The FDA product code is FRQ – Tube, Levine, a Class II (moderate risk) device regulated under 21 CFR 876.5980.