SCOPESCRUBBER(TM)
FDA 510(k) clearance K902683 · decided 1990-10-31
Clearance details
- K-number
- K902683
- Device name
- SCOPESCRUBBER(TM)
- Applicant
- Healthtek Microsurgical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1990-06-19
- Decision date
- 1990-10-31
- Days to decision
- 134 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
- Burlington, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.