Compound Benzoin Tincture Usp Sepp
FDA 510(k) K923516 · Medi-Flex Hospital Products, Inc.
510(k) numberK923516
Submission
- Device name
- Compound Benzoin Tincture Usp Sepp
- Applicant
- Medi-Flex Hospital Products, Inc.
Overland Park, KS, US - Received
- June 18, 1992
- Decision date
- January 25, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- KMF – Bandage, Liquid
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 880.5090
- Specialty
- General Hospital
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| K171148 | Aleo BME Liquid BandageKMF · Traditional | Aleo Bme, Inc. | 01/12/2018SE |
| K153571 | Cavilon Advanced High Endurance Skin ProtectantKMF · Traditional | 3M Healthcare | 08/23/2016SE |
| K160684 | Atteris No-Sting Skin ProtectantKMF · Traditional | Rochal Industries, LLC | 07/26/2016SE |
| K131384 | Kericure Advanced Liquid Bandage, Natural Seal Liquid Bandage, Liquid BandageKMF · Traditional | Kericure, Inc. | 08/07/2014SE |
| K133443 | Marathon No Sting Liquid Skin ProtectantKMF · Traditional | Advanced Medical Solutions (Plymouth), Ltd. | 07/10/2014SE |
| K120059 | Liquid BandageKMF · Traditional | Chesson Laboratory Associates, Inc. | 05/17/2012SE |
| K092712 | Skin Barrier FilmKMF · Traditional | Lodestar Products, Inc. | 02/23/2010SE |
| K083087 | EcocelKMF · Traditional | Polichem S.A | 08/07/2009SE |
More from Polichem S.A
| 510(k) | Device | Decision |
|---|---|---|
| K970441 | K-Klosure 2 Inch LENGTH/4 Inch LENGTH/8 Inch LENGTH/12 Inch LengthFPX · Traditional | 05/09/1997SE |
| K962740 | Dermistick Sepp APPLICATOR(200 CT)/(40 CT) 260640/260641KMF · Traditional | 09/06/1996SE |
| K952201 | Port-A-Cath Access KitFMF · Traditional | 10/04/1995SE |
| K952416 | Tracheostomy Care KitBTO · Traditional | 08/09/1995SESK |
| K952256 | Picc Line KitFOZ · Traditional | 07/31/1995SE |
| K952007 | Adherol Sepp ApplicatorFRO · Traditional | 06/08/1995SE |
| K934790 | Sepp Adhesive RemoverKOX · Traditional | 03/11/1994SE |
| K920399 | Compound Benzoin Tincture Usp FreppKMF · Traditional | 01/25/1994SE |
| K930196 | Cepti-Seal I.V. Prep KitLRS · Traditional | 07/02/1993SEKD |
| K921347 | Cepti-Seal Dressing Change Kit for Venous CatheterMCY · Traditional | 01/08/1993SEKD |
Questions and answers
When was Compound Benzoin Tincture Usp Sepp cleared by the FDA?
Compound Benzoin Tincture Usp Sepp (K923516) received a 510(k) decision of Substantially Equivalent on January 25, 1994, 586 days after the submission was received.
What is the product code of K923516?
The FDA product code is KMF – Bandage, Liquid, a Class I (low risk) device regulated under 21 CFR 880.5090.