Show'Rbag
FDA 510(k) K822059 · The Healthcare Group Laboratories, Inc.
510(k) numberK822059
Submission
- Device name
- Show'Rbag
- Applicant
- The Healthcare Group Laboratories, Inc.
Mchenry, IL, US - Received
- July 13, 1982
- Decision date
- July 22, 1982
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- LGF – Component, Cast
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 888.5940
- Specialty
- Orthopedic
Other 510(k)s with product code LGF
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K043526 | Silverseal Tubular Wound Dressing with X-StaticLGF · Traditional | Noble Fiber Technologies, Inc. | 03/10/2005SE |
| K973420 | Clinitex Cast PaddingLGF · Traditional | Clinitex Medical Corp. | 12/09/1997SE |
| K973417 | Clinitex StockinetteLGF · Traditional | Clinitex Medical Corp. | 12/09/1997SE |
| K955320 | Protec Cotton Padding BandageLGF · Traditional | Derivadas Degasa S.A. DE C.V. | 01/26/1996SE |
| K932507 | Quick-Cast ImmobilizerLGF · Traditional | Landec Corp. | 02/23/1994SE |
| K931672 | Carapace Sterile Cast PaddingLGF · Traditional | Carapace, Inc. | 12/15/1993SE |
| K910274 | Artiflex(Tm)LGF · Traditional | Beiersdorf, Inc. | 03/05/1991SE |
| K903946 | Cool Cast(R)LGF · Traditional | Hawthorne Products, Inc. | 12/31/1990SE |
| K896634 | Caraglas Xtra Synthetic Casting TapeLGF · Traditional | Buckman Co., Inc. | 06/14/1990SE |
| K883294 | Synthetic Cast TapeLGF · Traditional | Carapace, Inc. | 08/30/1988SE |
More from Carapace, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K850035 | Empty Solution Transfer ContainerKPE · Traditional | 06/07/1985SE |
| K842170 | Empty Solution Transfer ContainerKPE · Traditional | 10/19/1984SE |
| K842091 | Dispos. Acu-Cut Soft Tissue Biopsy · Traditional | 07/23/1984SE |
| K840742 | Right Atrial CatheterLJS · Traditional | 07/13/1984SE |
| K830299 | Solution Transfer ContainerKPE · Traditional | 02/19/1983SE |
| K822307 | Adhesive Spray #4050-4060KNX · Traditional | 09/24/1982SE |
| K821480 | Right Atrial Catheters Parenteral NutritDQY · Traditional | 06/17/1982SE |
| K821230 | Softic 49EBI · Traditional | 05/28/1982SE |
| K821162 | Adhesive RemoverKOX · Traditional | 05/14/1982SE |
| K821172 | External Female Urinary IncontinenceKNX · Traditional | 05/10/1982SE |
Questions and answers
When was Show'Rbag cleared by the FDA?
Show'Rbag (K822059) received a 510(k) decision of Substantially Equivalent on July 22, 1982, 9 days after the submission was received.
What is the product code of K822059?
The FDA product code is LGF – Component, Cast, a Class I (low risk) device regulated under 21 CFR 888.5940.