# Medical Device; Exemption From Premarket Notification; Class II Devices; Barium Enema Retention Catheters and Tips With or Without a Bag
> **Food and Drug Administration** · Final rule. · Published 2000-12-08 · Effective 2000-12-08 · 65 FR 76930
## Document
- **Document number:** 00-31292
- **Category:** fda-device
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 65 FR 76930
- **CFR reference:** 21 CFR 876
- **Publication date:** 2000-12-08
- **Effective date:** 2000-12-08
- **HHS docket:** Docket No. 00P-1343
## Abstract

The Food and Drug Administration (FDA) is publishing an order granting a petition requesting exemption from the premarket notification requirements for barium enema retention catheters and tips with or without a bag with certain limitations. This rule will exempt from premarket notification barium enema retention catheters and tips with or without a bag. FDA is publishing this order in accordance with procedures established by the Food and Drug Administration Modernization Act of 1997 (FDAMA).

## Source
- [Federal Register document](https://www.federalregister.gov/documents/2000/12/08/00-31292/medical-device-exemption-from-premarket-notification-class-ii-devices-barium-enema-retention)
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