MIDAS REX III MOTOR AND ATTACHMENTS (MIDAS III)
FDA 510(k) clearance K970965 · decided 1997-04-09
Clearance details
- K-number
- K970965
- Device name
- MIDAS REX III MOTOR AND ATTACHMENTS (MIDAS III)
- Applicant
- Midas Rex Pneumatic Tools, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1997-03-17
- Decision date
- 1997-04-09
- Days to decision
- 23 days
- Clearance type
- Traditional
- Product code
- ERL
- Device class
- 2
- Regulation number
- 874.4250
- Medical specialty
- Ear, Nose, Throat
- Advisory committee
- Ear, Nose, Throat
- Location
- Fort Worth, TX, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.