CONTROL SYRINGE
FDA 510(k) clearance K972655 · decided 1997-11-04
Clearance details
- K-number
- K972655
- Device name
- CONTROL SYRINGE
- Applicant
- Medical Specialties Intl., Inc.
- Decision
- Substantially Equivalent
- Date received
- 1997-07-15
- Decision date
- 1997-11-04
- Days to decision
- 112 days
- Clearance type
- Traditional
- Product code
- IZI
- Device class
- 2
- Regulation number
- 892.1600
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Tarpon Springs, FL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.