ENTELLAN
FDA 510(k) clearance K800847 · decided 1980-05-08
Clearance details
- K-number
- K800847
- Device name
- ENTELLAN
- Applicant
- Mcb Manufacturing Chemists, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1980-04-15
- Decision date
- 1980-05-08
- Days to decision
- 23 days
- Clearance type
- Traditional
- Product code
- KEP
- Device class
- 1
- Regulation number
- 864.4010
- Medical specialty
- Pathology
- Advisory committee
- Pathology
- 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 |
|---|---|---|
| CLEARIUM, MOUNTING MEDIUM (K830659) | Surgipath Medical Industries, Inc. | 1983-03-17 |
| ACRYTOL, MOUNTING MEDIUM (K810323) | Surgipath | 1981-03-06 |
Recalls involving this device
No recalls on record reference this clearance.