STEAM DOT BLU PROCESS INDICATOR
FDA 510(k) clearance K111453 · decided 2012-04-05
Clearance details
- K-number
- K111453
- Device name
- STEAM DOT BLU PROCESS INDICATOR
- Applicant
- Propper Mfg. Co., Inc.
- Decision
- Substantially Equivalent
- Date received
- 2011-05-25
- Decision date
- 2012-04-05
- Days to decision
- 316 days
- Clearance type
- Abbreviated
- Product code
- JOJ
- Device class
- 2
- Regulation number
- 880.2800
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Long Island, NY, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.