OP-CON SURGICAL INSTRUMENT #9
FDA 510(k) clearance K834540 · decided 1984-03-06
Clearance details
- K-number
- K834540
- Device name
- OP-CON SURGICAL INSTRUMENT #9
- Applicant
- Imm Enterprises , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 1983-12-01
- Decision date
- 1984-03-06
- Days to decision
- 96 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 |
|---|---|---|
| MOUTH GAGS (K822183) | Kelleher Corp. | 1982-08-16 |
| MILLARD MOUTH GAG (K780992) | Nestor Engineering Associates, Inc. | 1978-08-17 |
Recalls involving this device
No recalls on record reference this clearance.