W & H LISA STEAM STERILIZER— 510(k) K022816
Substantially EquivalentA-Dec, Inc.
FDA 510(k) clearance K022816 for W & H LISA STEAM STERILIZER, Substantially Equivalent on 2003-02-07. Applicant: A-Dec, Inc.. Device class: 2.
Clearance details
- Applicant
- A-Dec, Inc.
- Product code
- Code FLE
- Device class
- Class 2
- Regulation
- 21 CFR 880.6880
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Location
- Newberg, OR, US
Recent devices under product code FLE
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view all- K213932 — A-dec 300, A-dec 500
- K133776 — A-DEC/W&H ELECTRIC HANDPIECE MOTOR
- K102234 — A-DEC 200 DENTAL SYSTEM
- K100647 — A-DEC/W&H SYNEA SONIC SCALER HANDPIECE, MODELS ZA-55, ZA-55 L, ZA-55 LM, ZA-55M, SF1LM
- K082716 — A-DEC/W&H ALEGRA AIR-DRIVEN HIGHSPEED HANDPIECE, MODEL TE-97, TE-98, A-DEC/W&H ALEGRA HANDPIECE ATTACHMENT, MODEL HE-43
Adverse events under product code FLE
product code FLE- Malfunction
- 444
- Total
- 444
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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.