C-Section, Labor & Delivery Trays (Packs)
FDA 510(k) K932216 · Associated Medical Products Co.
510(k) numberK932216
Submission
- Device name
- C-Section, Labor & Delivery Trays (Packs)
- Applicant
- Associated Medical Products Co.
St. Louis Park, MN, US - Received
- May 7, 1993
- Decision date
- April 19, 1994
- Decision
- Unknown (SESK)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- MLS – Labor And Delivery Kit
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.4530
- Specialty
- Obstetrics/Gynecology
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
Other 510(k)s with product code MLS
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K961993 | Birthday Kit (Obstetrical Delivery Kit)MLS · Traditional | Devon Industries, Inc. | 07/03/1996SE |
| K960243 | CPR C-Section Delivery PackMLS · Traditional | Custom Pack Reliability | 05/23/1996SE |
| K940518 | C-Section TrayMLS · Traditional | Cush Medical Products | 08/18/1994SEKD |
| K936120 | Labor and Delivery TrayMLS · Traditional | Cush Medical Products | 03/30/1994SEKD |
| K931722 | Carapace Labor and Delivery SetsMLS · Traditional | Carapace, Inc. | 03/23/1994SEKD |
More from Carapace, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K932221 | Neurological or Crani Trays (Packs)LRO · Traditional | 03/19/1997SE |
| K930507 | Custom Orthopaedic Trays (Packs)HTS · Traditional | 02/22/1994SE |
| K932217 | Major, Minor, Basin Trays (Packs)LRO · Traditional | 11/15/1993SESK |
| K932220 | Lap Choly Trays (Packs)LRO · Traditional | 09/27/1993SESK |
| K932218 | Cardiac Cath or Angiographic TraysDQO · Traditional | 08/27/1993SEKD |
| K932219 | Suture Set or Laceration Trays (Packs)KDD · Traditional | 07/09/1993SESK |
| K842983 | Ampco Opthalmic TrayHOZ · Traditional | 05/22/1985SE |
| K843114 | Ampco Procedure Trays / Packs · Traditional | 08/08/1984SESP |
| K823839 | Ampco Kidney Dialysis TrayKOC · Traditional | 03/29/1983SE |
| K821579 | Skin Scrub-TrayLDR · Traditional | 07/21/1982SE |
Questions and answers
When was C-Section, Labor & Delivery Trays (Packs) cleared by the FDA?
C-Section, Labor & Delivery Trays (Packs) (K932216) received a 510(k) decision of Unknown on April 19, 1994, 347 days after the submission was received.
What is the product code of K932216?
The FDA product code is MLS – Labor And Delivery Kit, a Class II (moderate risk) device regulated under 21 CFR 884.4530.