MOUTH GAGS
FDA 510(k) clearance K822183 · decided 1982-08-16
Clearance details
- K-number
- K822183
- Device name
- MOUTH GAGS
- Applicant
- Kelleher Corp.
- Decision
- Substantially Equivalent
- Date received
- 1982-07-23
- Decision date
- 1982-08-16
- Days to decision
- 24 days
- Clearance type
- Traditional
- Product code
- KBN
- Device class
- 1
- Regulation number
- 874.4420
- Medical specialty
- Ear, Nose, Throat
- Advisory committee
- Ear, Nose, Throat
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| OP-CON SURGICAL INSTRUMENT #9 (K834540) | Imm Enterprises , Ltd. | 1984-03-06 |
| MILLARD MOUTH GAG (K780992) | Nestor Engineering Associates, Inc. | 1978-08-17 |
Recalls involving this device
No recalls on record reference this clearance.