← Product Code [HDD](/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/HDD) · K950889

# ADEL 5000 (K950889)

_Stryker Corp. · HDD · Oct 16, 1995 · Obstetrics/Gynecology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/HDD/K950889

## Device Facts

- **Applicant:** Stryker Corp.
- **Product Code:** [HDD](/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/HDD.md)
- **Decision Date:** Oct 16, 1995
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 884.4900
- **Device Class:** Class 2
- **Review Panel:** Obstetrics/Gynecology

## Regulatory Identification

An obstetric table is a device with adjustable sections designed to support a patient in the various positions required during obstetric and gynecologic procedures. This generic type of device may include the following accessories: patient equipment, support attachments, and cabinets for warming instruments and disposing of wastes.

## Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.

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**Source:** [https://fda.innolitics.com/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/HDD/K950889](https://fda.innolitics.com/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/HDD/K950889)

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