LUCAE'S EAR & NASAL APPLICATORS
FDA 510(k) clearance K832667 · decided 1983-09-29
Clearance details
- K-number
- K832667
- Device name
- LUCAE'S EAR & NASAL APPLICATORS
- Applicant
- Kells Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1983-08-09
- Decision date
- 1983-09-29
- Days to decision
- 51 days
- Clearance type
- Traditional
- Product code
- KCJ
- Device class
- 1
- Regulation number
- 874.5220
- 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 |
|---|---|---|
| ENDOPATH TISSUE RETAINING COMPONENT (K923679) | Ethicon Endo-Surgery, Inc. | 1992-09-09 |
| LAPAROMED LIGATING LOOP (K921053) | Laparomed Corp. | 1992-08-06 |
| APDYNE PHENOL APPLICATOR KIT (K894369) | Apdyne Medical Co. | 1989-10-12 |
Recalls involving this device
No recalls on record reference this clearance.