Cool Cast(R)
FDA 510(k) K903946 · Hawthorne Products, Inc.
510(k) numberK903946
Submission
- Device name
- Cool Cast(R)
- Applicant
- Hawthorne Products, Inc.
Dunkirk, IN, US - Received
- August 27, 1990
- Decision date
- December 31, 1990
- 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 |
| K896634 | Caraglas Xtra Synthetic Casting TapeLGF · Traditional | Buckman Co., Inc. | 06/14/1990SE |
| K883294 | Synthetic Cast TapeLGF · Traditional | Carapace, Inc. | 08/30/1988SE |
| K874880 | Colored Casting Tape Caraglas(Tm GreenLGF · Traditional | Synthetic Mfg., Inc. | 12/30/1987SE |
Questions and answers
When was Cool Cast(R) cleared by the FDA?
Cool Cast(R) (K903946) received a 510(k) decision of Substantially Equivalent on December 31, 1990, 126 days after the submission was received.
What is the product code of K903946?
The FDA product code is LGF – Component, Cast, a Class I (low risk) device regulated under 21 CFR 888.5940.