STERITITE PERFORATED BASE RIGID REUSABLE STERILIZATION CONTAINER SYSTEM WITH SCF02-POLYPROPYLENE NON-WOVEN DISPOSABLE FI— 510(k) K030853
Substantially EquivalentCase Medical, Inc.
FDA 510(k) clearance K030853 for STERITITE PERFORATED BASE RIGID REUSABLE STERILIZATION CONTAINER SYSTEM WITH SCF02-POLYPROPYLENE NON-WOVEN DISPOSABLE FI, Substantially Equivalent on 2003-03-21. Applicant: Case Medical, Inc.. Device class: 2.
Clearance details
- Applicant
- Case Medical, Inc.
- Product code
- Code FRG
- Device class
- Class 2
- Regulation
- 21 CFR 880.6850
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Ridgefield, NJ, US
Recent devices under product code FRG
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- K161415 — SteriTite Containers System & MediTray Products
Adverse events under product code FRG
product code FRG- Other
- 3
- Total
- 3
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K030853
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 K030853.
Data sourced from openFDA. This site is unofficial and independent of the FDA.