DRAINAGE BAG— 510(k) K990428
Substantially EquivalentRemington Medical, Inc.
FDA 510(k) clearance K990428 for DRAINAGE BAG, Substantially Equivalent on 1999-08-12. Applicant: Remington Medical, Inc.. Device class: 2.
Clearance details
- Applicant
- Remington Medical, Inc.
- Product code
- Code EXF
- Device class
- Class 2
- Regulation
- 21 CFR 876.5010
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Alpharetta, GA, US
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Recalls naming K990428
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K990428.
Data sourced from openFDA. This site is unofficial and independent of the FDA.