Conphar Cast Heels
FDA 510(k) K803141 · Conphar, Inc.
510(k) numberK803141
Submission
- Device name
- Conphar Cast Heels
- Applicant
- Conphar, Inc.
Mchenry, IL, US - Received
- December 12, 1980
- Decision date
- January 9, 1981
- 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 |
|---|---|---|
| K821825 | Conphar Silicone Feeding TubeKNT · Traditional | 08/10/1982SE |
| K821354 | Conphar Mayo Hegar Needle HolderGDF · Traditional | 06/03/1982SE |
| K821295 | Olsen Hegar Needle HoldersGDF · Traditional | 06/03/1982SE |
| K821289 | Mayo-Hegar Needle HolderGDF · Traditional | 06/03/1982SE |
| K821298 | Backhaus Clamp, 3 1/2HTD · Traditional | 05/28/1982SE |
| K821294 | Tonsil Scissors Straight 5 1/2EGN · Traditional | 05/28/1982SE |
| K821293 | Backhaus Clamp, 5 1/4HTD · Traditional | 05/28/1982SE |
| K821292 | Tonsil Scissors 7EGN · Traditional | 05/28/1982SE |
| K821290 | Littauer Scissors 5 1/2HNF · Traditional | 05/28/1982SE |
| K821286 | Iris Scissors Straight 4 1/2HNF · Traditional | 05/28/1982SE |
Questions and answers
When was Conphar Cast Heels cleared by the FDA?
Conphar Cast Heels (K803141) received a 510(k) decision of Substantially Equivalent on January 9, 1981, 28 days after the submission was received.
What is the product code of K803141?
The FDA product code is LGF – Component, Cast, a Class I (low risk) device regulated under 21 CFR 888.5940.