CONCEPT CANALICULUS INTUBATION SET
FDA 510(k) clearance K802845 · decided 1980-12-17
Clearance details
- K-number
- K802845
- Device name
- CONCEPT CANALICULUS INTUBATION SET
- Applicant
- Concept, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1980-11-12
- Decision date
- 1980-12-17
- Days to decision
- 35 days
- Clearance type
- Traditional
- Product code
- HNL
- Device class
- 1
- Regulation number
- 886.4350
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- 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 |
|---|---|---|
| CONCEPT FIBER OPTIC CANALICULUS INTUBA (K843491) | Concept, Inc. | 1984-10-05 |
| TSE-ANDERSON MODIFIED LACRIMAL GROOV (K840861) | Hansen Ophthalmic Development Lab | 1984-05-09 |
| STERILE OIL AND GUIDEWIRE (K833671) | CooperVision, Inc. | 1984-01-10 |
| LACIMAL INTUBATION SETS (K831901) | Visitec Co. | 1983-07-12 |
| PILLING LACRIMAL INTUBATION SYSTEM (K813187) | Narco Scientific | 1982-01-28 |
| ETHICON LACRIMAL STENT (K812255) | ETHICON, Inc. | 1981-08-20 |
| JACKSON LACRIMAL INTUBATION SET (K801232) | Storz Instrument Co. | 1980-06-17 |
| CRAWFORD LACRIMAL INTUBATION SET (K800089) | Jedmed Instrument Co. | 1980-03-03 |
| NASO-LACRIMAL DUCT INSERT (K770194) | Concept, Inc. | 1977-02-14 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| HUNTER-SESSIONS VENA-CAVA OCCLUDER (P770005) | Concept, Inc. | 1977-12-19 |