MLS — Labor And Delivery Kit Class II
Classification Details
- Product Code
- MLS
- Device Class
- Class II
- Regulation Number
- 884.4530
- Submission Type
- Review Panel
- OB
- Medical Specialty
- Obstetrics/Gynecology
- Implant
- No
Definition
This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K961993 | devon industries | BIRTHDAY KIT (OBSTETRICAL DELIVERY KIT) | July 3, 1996 |
| K960243 | custom pack reliability | CPR C-SECTION DELIVERY PACK | May 23, 1996 |
| K940518 | cush medical products | C-SECTION TRAY | August 18, 1994 |
| K932216 | associated medical products | C-SECTION, LABOR & DELIVERY TRAYS (PACKS) | April 19, 1994 |
| K936120 | cush medical products | LABOR AND DELIVERY TRAY | March 30, 1994 |
| K931722 | carapace | CARAPACE LABOR AND DELIVERY SETS | March 23, 1994 |