Sterilization Process/T-Binder
FDA 510(k) K792629 · Procter & Gamble Mfg. Co.
510(k) numberK792629
Submission
- Device name
- Sterilization Process/T-Binder
- Applicant
- Procter & Gamble Mfg. Co.
Mchenry, IL, US - Received
- December 19, 1979
- Decision date
- January 11, 1980
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KMO – Binder, Elastic
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 880.5160
- Specialty
- General Hospital
Other 510(k)s with product code KMO
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K921852 | 4 Sure TM Rectal TubeKMO · Traditional | Boston Pacific Medical, Inc. | 10/08/1993SE |
| K893809 | Cough PillowKMO · Traditional | Custom Hospitals Products | 08/28/1989SE |
| K883214 | Thoracic Support SystemKMO · Traditional | Storer Medical Products | 01/17/1989SE |
| K882592 | Heart Hugger Sternum Support HarnessKMO · Traditional | General Cardiac Technology, Inc. | 09/20/1988SE |
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| K873036 | Attends Incontinent BriefEYQ · Traditional | 01/19/1988SE |
| K864673 | Unscented Menstrual PadHHL · Traditional | 01/21/1987SE |
| K861863 | Modified Protective GarmentEYQ · Traditional | 08/11/1986SE |
| K862348 | Single-Use Patient UnderpadKME · Traditional | 07/02/1986SE |
| K860598 | Modified Protective Garment for IncontinentsEYQ · Traditional | 03/05/1986SE |
| K853880 | Attends Dispos. UnderpadKME · Traditional | 10/16/1985SE |
| K853000 | Scented Always PantilinersHHL · Traditional | 09/06/1985SE |
| K852985 | Unscented Always PantilinersHHD · Traditional | 08/29/1985SE |
| K850956 | Always Maxipads - ScentedHHL · Traditional | 05/14/1985SE |
Questions and answers
When was Sterilization Process/T-Binder cleared by the FDA?
Sterilization Process/T-Binder (K792629) received a 510(k) decision of Substantially Equivalent on January 11, 1980, 23 days after the submission was received.
What is the product code of K792629?
The FDA product code is KMO – Binder, Elastic, a Class I (low risk) device regulated under 21 CFR 880.5160.