← Product Code [JOL](/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/JOL) · K000266

# PRIMARY CARE SOLUTIONS STERILE SALINE-0.9% SODIUM CHLORIDE FOR DEVICE IRRIGATION (K000266)

_Primary Care Solutions, Inc. · JOL · Jul 12, 2001 · General Hospital · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/JOL/K000266

## Device Facts

- **Applicant:** Primary Care Solutions, Inc.
- **Product Code:** [JOL](/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/JOL.md)
- **Decision Date:** Jul 12, 2001
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 880.6740
- **Device Class:** Class 2
- **Review Panel:** General Hospital

## Regulatory Identification

A vacuum-powered body fluid suction apparatus is a device used to aspirate, remove, or sample body fluids. The device is powered by an external source of vacuum. This generic type of device includes vacuum regulators, vacuum collection bottles, suction catheters and tips, connecting flexible aspirating tubes, rigid suction tips, specimen traps, noninvasive tubing, and suction regulators (with gauge).

## 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 § 880.9.

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**Source:** [https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/JOL/K000266](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/JOL/K000266)

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