MINISPACER DUAL-SPRAY MDI ADAPTER WITH 22MM (OR 15MM) OD / 22MM OD/ID CONNECTIONS / 15MM ID CONNECTIONS
FDA 510(k) clearance K102658 · decided 2010-12-10
Clearance details
- K-number
- K102658
- Device name
- MINISPACER DUAL-SPRAY MDI ADAPTER WITH 22MM (OR 15MM) OD / 22MM OD/ID CONNECTIONS / 15MM ID CONNECTIONS
- Applicant
- Thayer Medical Corp.
- Decision
- Substantially Equivalent
- Date received
- 2010-09-15
- Decision date
- 2010-12-10
- Days to decision
- 86 days
- Clearance type
- Special
- Product code
- CAF
- Device class
- 2
- Regulation number
- 868.5630
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Tucson, AZ, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.