Anago Fem-Cool/Fem-Cool Petite
FDA 510(k) K926137 · Anago, Inc.
510(k) numberK926137
Submission
- Device name
- Anago Fem-Cool/Fem-Cool Petite
- Applicant
- Anago, Inc.
Fort Worth, TX, US - Received
- December 7, 1992
- Decision date
- May 26, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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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More from Allegiance Healthcare Corp.
| 510(k) | Device | Decision |
|---|---|---|
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| K926590 | Anago Disposable Instant Cold PackIMD · Traditional | 05/26/1993SE |
| K926589 | Anago Warm PackIMD · Traditional | 05/26/1993SE |
| K920615 | Anago Continuous Epidural Anesthesia Tray/KitCAZ · Traditional | 03/20/1993SEKD |
| K915415 | Guardall ShieldLYU · Traditional | 10/15/1992SE |
| K913558 | Reliable Cone Style Face MaskFXX · Traditional | 11/07/1991SE |
| K905865 | Anti-For Surgical Face MaskFXX · Traditional | 03/06/1991SE |
| K905749 | Surgical Face MaskFXX · Traditional | 03/04/1991SE |
| K904276 | Disposable Beard CoverFXY · Traditional | 11/21/1990SE |
Questions and answers
When was Anago Fem-Cool/Fem-Cool Petite cleared by the FDA?
Anago Fem-Cool/Fem-Cool Petite (K926137) received a 510(k) decision of Substantially Equivalent on May 26, 1993, 170 days after the submission was received.
What is the product code of K926137?
The FDA product code is IMD – Pack, Hot Or Cold, Disposable, a Class I (low risk) device regulated under 21 CFR 890.5710.