Sterilization Process/Placenta Basin
FDA 510(k) K792625 · Procter & Gamble Mfg. Co.
510(k) numberK792625
Submission
- Device name
- Sterilization Process/Placenta Basin
- Applicant
- Procter & Gamble Mfg. Co.
Mchenry, IL, US - Received
- December 19, 1979
- Decision date
- January 16, 1980
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- FNY – Basin, Emesis
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 880.6730
- Specialty
- General Hospital
Other 510(k)s with product code FNY
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K832826 | Aap Dosimetry Release or Basin SetsFNY · Traditional | American Hospital Supply Corp. | 04/23/1984SE |
| K802538 | Basin PackFNY · Traditional | Texas Medical Products, Inc. | 10/31/1980SE |
| K800440 | Sterile Sponge BowlsFNY · Traditional | Premium Plastics, Inc. | 04/29/1980SE |
| K771733 | 8 Emesis BasinFNY · Traditional | Bemis Health Care | 09/28/1977SE |
| K760495 | Basin, Rectangular WashFNY · Traditional | Landmark Plastics | 11/12/1976SE |
| K760494 | Basin, Round WashFNY · Traditional | Landmark Plastics | 11/12/1976SE |
| K760492 | Basin, Large or SmallFNY · Traditional | Landmark Plastics | 11/12/1976SE |
| K760085 | Basin, Sterile (#3200)FNY · Traditional | Concord Laboratories, Inc. | 07/20/1976SE |
More from Concord Laboratories, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K873457 | Scented or Scented Deodorized Menstrual PadsHIL · Traditional | 01/19/1988SE |
| 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/Placenta Basin cleared by the FDA?
Sterilization Process/Placenta Basin (K792625) received a 510(k) decision of Substantially Equivalent on January 16, 1980, 28 days after the submission was received.
What is the product code of K792625?
The FDA product code is FNY – Basin, Emesis, a Class I (low risk) device regulated under 21 CFR 880.6730.