Guaze Bandages CAT.#101-169
FDA 510(k) K801996 · Pollak (Intl.), Ltd.
510(k) numberK801996
Submission
- Device name
- Guaze Bandages CAT.#101-169
- Applicant
- Pollak (Intl.), Ltd.
Mchenry, IL, US - Received
- August 20, 1980
- Decision date
- September 16, 1980
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- NAB – Gauze / Sponge,Nonresorbable For External Use
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4014
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code NAB
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K946015 | Ivalon External SpongeNAB · Traditional | Ivalon | 02/27/1995SE |
| K940755 | Isolyer (4X4, 8PLY)NAB · Traditional | Isolyer Co. | 05/02/1994SE |
| K931610 | Omnisorb II, Nonwoven Sponge, Sterile and NonNAB · Traditional | Omni Mfg., Inc. | 06/24/1993SE |
| K925590 | Multi-Trauma DressingNAB · Traditional | Gam Industries, Inc. | 04/08/1993SE |
| K926072 | K-Band and K-CrepeNAB · Traditional | Parema , Ltd. | 03/19/1993SE |
| K915591 | Sterile Gauze PadsNAB · Traditional | Eagle Medical, Inc. | 01/27/1993SE |
| K924650 | Gauze SpongesNAB · Traditional | Dav-Mar Medical Products, Inc. | 01/11/1993SE |
| K923602 | Absorbent Pad -- ModificationNAB · Traditional | Winfield Laboratories, Inc. | 12/07/1992SE |
| K923115 | ClinisorbNAB · Traditional | Hermitage Hospital Products, Inc. | 11/23/1992SE |
| K923378 | Usp Type Vii Gauze SpongesNAB · Traditional | E.W.A., Ltd. | 10/06/1992SE |
More from E.W.A., Ltd.
| 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 Guaze Bandages CAT.#101-169 cleared by the FDA?
Guaze Bandages CAT.#101-169 (K801996) received a 510(k) decision of Substantially Equivalent on September 16, 1980, 27 days after the submission was received.
What is the product code of K801996?
The FDA product code is NAB – Gauze / Sponge,Nonresorbable For External Use, a Class I (low risk) device regulated under 21 CFR 878.4014.