Plastic Disposable Razor CAT.#1017,1018
FDA 510(k) K802003 · Pollak (Intl.), Ltd.
510(k) numberK802003
Submission
- Device name
- Plastic Disposable Razor CAT.#1017,1018
- Applicant
- Pollak (Intl.), Ltd.
Mchenry, IL, US - Received
- August 20, 1980
- Decision date
- September 9, 1980
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
No product code recorded.
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| K981032 | Piv SystemLDQ · Traditional | Medical Solutions, Inc. | 09/02/1998SE |
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| K955776 | Acu-LabLDQ · Traditional | Glederer & Co., Inc. | 06/05/1996SE |
| K945374 | Acu-HaltLDQ · Traditional | Eva-Health USA, Inc. | 08/09/1995SE |
| K944961 | Personal Alarm System (Pas)LDQ · Traditional | Cytoprobe Corp. | 08/07/1995SE |
| K942810 | Palco Labs Cold PouchLDQ · Traditional | Palco Laboratories, Inc. | 06/28/1995SE |
| K930884 | Medical Procedure Tray, ModificationLDQ · Traditional | Enpak Medical Corp. | 03/21/1995SE |
More from Enpak Medical Corp.
| 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 |
| K802007 | Pediwet=Guaze Impregnated with PetrolFRQ · Traditional | 09/26/1980SE |
| 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 |
Questions and answers
When was Plastic Disposable Razor CAT.#1017,1018 cleared by the FDA?
Plastic Disposable Razor CAT.#1017,1018 (K802003) received a 510(k) decision of Substantially Equivalent on September 9, 1980, 20 days after the submission was received.