PuraStat-OM
FDA 510(k) clearance K210211 · decided 2021-10-08
Clearance details
- K-number
- K210211
- Device name
- PuraStat-OM
- Applicant
- 3-D Matrix, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2021-01-27
- Decision date
- 2021-10-08
- Days to decision
- 254 days
- Clearance type
- Traditional
- Product code
- OLR
- Device class
- U
- Medical specialty
- Unknown
- Advisory committee
- Unknown
- Location
- Newton, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.