DEROYAL INDUSTRIES, INC. DEFOGGER— 510(k) K982465
Substantially EquivalentDeroyal Industries, Inc.
FDA 510(k) clearance K982465 for DEROYAL INDUSTRIES, INC. DEFOGGER, Substantially Equivalent on 1998-08-11. Applicant: Deroyal Industries, Inc.. Device class: 2.
Clearance details
- Applicant
- Deroyal Industries, Inc.
- Product code
- Code OCT
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Powell, TN, US
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Recalls naming K982465
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 K982465.
Data sourced from openFDA. This site is unofficial and independent of the FDA.