TONSIL SPONGE, GAUZE DISSECTOR, CYLINDRICAL SPONGES
FDA 510(k) clearance K940903 · decided 1994-04-14
Clearance details
- K-number
- K940903
- Device name
- TONSIL SPONGE, GAUZE DISSECTOR, CYLINDRICAL SPONGES
- Applicant
- Medical Insights, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1994-02-24
- Decision date
- 1994-04-14
- Days to decision
- 49 days
- Clearance type
- Traditional
- Product code
- KBM
- Device class
- 1
- Regulation number
- 874.4420
- Medical specialty
- Ear, Nose, Throat
- Advisory committee
- Ear, Nose, Throat
- Location
- Mystic, CT, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.