WA-2000 TEMPERATURE INDICATOR
FDA 510(k) clearance K813402 · decided 1982-01-12
Clearance details
- K-number
- K813402
- Device name
- WA-2000 TEMPERATURE INDICATOR
- Applicant
- Wallach Surgical Devices, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1981-12-04
- Decision date
- 1982-01-12
- Days to decision
- 39 days
- Clearance type
- Traditional
- Product code
- FLL
- Device class
- 2
- Regulation number
- 880.2910
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.