Cp&S Disposable Instant Super Hot Compress
FDA 510(k) K890554 · Consolidated Products & Services, Inc.
510(k) numberK890554
Submission
- Device name
- Cp&S Disposable Instant Super Hot Compress
- Applicant
- Consolidated Products & Services, Inc.
North Quincy, MA, US - Received
- February 6, 1989
- Decision date
- February 13, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- IMD – Pack, Hot Or Cold, Disposable
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 890.5710
- Specialty
- Physical Medicine
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| K082087 | Eyefeel Ophthalmic WarmerIMD · Traditional | Bio-Lipid, Inc. | 09/11/2008SE |
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| K021843 | Eyefeel Ophthalmic WarmerIMD · Traditional | Bio-Lipid, Inc. | 09/03/2002SE |
| K982652 | Allegiance Porta-Warm MattressIMD · Traditional | Allegiance Healthcare Corp. | 01/21/1999SE |
| K980509 | Deroyal Industries, Inc. Infant Transport MattressIMD · Traditional | Deroyal Industries, Inc. | 02/26/1998SE |
| K974190 | Cp&S Instant Cold Pack Limb Kit TransporterIMD · Traditional | Consolidated Products & Services, Inc. | 11/19/1997SE |
| K973770 | Allegiance Kwik Heat Warm Perineal PackIMD · Traditional | Allegiance Healthcare Corp. | 11/13/1997SE |
More from Allegiance Healthcare Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K974190 | Cp&S Instant Cold Pack Limb Kit TransporterIMD · Traditional | 11/19/1997SE |
| K930759 | CP & S Sterile Burn SheetFPY · Traditional | 01/21/1994SE |
| K890551 | Urinary Drainage UnitKNX · Traditional | 02/28/1989SE |
| K890550 | Cp&S Disposable Urinary Legbag (Medium & Large)KNX · Traditional | 02/28/1989SE |
| K890552 | Cp&S Gavage Constainer, DisposableKNT · Traditional | 02/24/1989SE |
| K890553 | Cp&S Disposable Instant Cold CompressIMD · Traditional | 02/13/1989SE |
Questions and answers
When was Cp&S Disposable Instant Super Hot Compress cleared by the FDA?
Cp&S Disposable Instant Super Hot Compress (K890554) received a 510(k) decision of Substantially Equivalent on February 13, 1989, 7 days after the submission was received.
What is the product code of K890554?
The FDA product code is IMD – Pack, Hot Or Cold, Disposable, a Class I (low risk) device regulated under 21 CFR 890.5710.