Tape, Elastoplast Elastic Tear
FDA 510(k) K781931 · Beiersdorf, Inc.
510(k) numberK781931
Submission
- Device name
- Tape, Elastoplast Elastic Tear
- Applicant
- Beiersdorf, Inc.
Mchenry, IL, US - Received
- November 20, 1978
- Decision date
- December 7, 1978
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- FQM – Bandage, Elastic
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 880.5075
- Specialty
- General Hospital
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|---|---|---|---|
| K040936 | Petit Silma Elastic Bandage with Germanium/Titanium OxideFQM · Traditional | Leda Co., Ltd. | 05/03/2004SE |
| K040054 | Back in Action Compression & Support with Magnets for the Lower Back, Knee and AnkleFQM · Traditional | Theodore Barash | 04/27/2004SE |
| K013244 | Comfortcare Compression Support Witih Magnets and Aegis Microbe Shield Comfortcare…FQM · Traditional | Med Gen, Inc. | 12/07/2001SE |
| K952738 | Skin Saver SystemsFQM · Traditional | Skin Saver Systems, Inc. | 09/29/1995SE |
| K872868 | Aspen Esmark BandageFQM · Traditional | Aspen Laboratories, Inc. | 07/31/1987SE |
| K840107 | Tube-Bandage for Human Digits 200FQM · Traditional | Zens Health Care Products | 04/25/1984SE |
| K831728 | MedicalexFQM · Traditional | Medicalex | 01/09/1984SE |
| K830622 | Ortho WrapFQM · Traditional | Fast Wrap Co., Inc. | 06/20/1983SE |
| K831551 | Compressogrip Tubular Elastic BandageFQM · Traditional | Fred Sammons, Inc. | 06/07/1983SE |
| K820142 | Tubular StockinetteFQM · Traditional | Stan-Pak Ent. | 02/05/1982SE |
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| K032463 | Curad Silver BandageFRO · Traditional | 02/10/2004SE |
| K032462 | Curad Silver Active Gel BandageFRO · Traditional | 02/10/2004SE |
| K024057 | Curad Scar TherapyMDA · Traditional | 06/18/2003SE |
| K022645 | CuradKMF · Traditional | 11/05/2002SE |
| K952526 | Cutinova CavityKMF · Traditional | 08/14/1995SN |
| K943363 | Cutiplast SterilMGP · Traditional | 03/15/1995SE |
| K944581 | Cutinova Thin Wound DressingKMF · Traditional | 12/02/1994SN |
| K935630 | NortaEZL · Traditional | 10/07/1994SE |
| K940378 | Coverlet Adhesive DressingKGX · Traditional | 07/29/1994SN |
Questions and answers
When was Tape, Elastoplast Elastic Tear cleared by the FDA?
Tape, Elastoplast Elastic Tear (K781931) received a 510(k) decision of Substantially Equivalent on December 7, 1978, 17 days after the submission was received.
What is the product code of K781931?
The FDA product code is FQM – Bandage, Elastic, a Class I (low risk) device regulated under 21 CFR 880.5075.