ULTRATHIN FLEXIBLE ENDOSCOPE TAS-211/2.3
FDA 510(k) clearance K936257 · decided 1994-03-24
Clearance details
- K-number
- K936257
- Device name
- ULTRATHIN FLEXIBLE ENDOSCOPE TAS-211/2.3
- Applicant
- Mitsubishi Cable America, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1993-12-30
- Decision date
- 1994-03-24
- Days to decision
- 84 days
- Clearance type
- Traditional
- Product code
- EOB
- Device class
- 2
- Regulation number
- 874.4760
- Medical specialty
- Ear, Nose, Throat
- Advisory committee
- Ear, Nose, Throat
- Location
- Maywood, NJ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.